Lucentis Drug Information
Generic name: RANIBIZUMAB
Vascular Endothelial Growth Factor Inhibitor [EPC]
Uses of Lucentis
Neovascular (Wet) Age-Related Macular Degeneration (AMD)
Macular Edema Following Retinal Vein Occlusion (RVO)
Diabetic Macular Edema (DME)
Diabetic Retinopathy (DR)
Myopic Choroidal
Neovascularization (mCNV)
Dosage & Administration of Lucentis
Preparation for Administration Prefilled Syringe
The prefilled syringe is sterile and is for single-dose only. Do not use the product if the packaging is damaged or has been tampered with. To prepare LUCENTIS for intravitreal administration, please adhere to these instructions for use.
Read all the instructions carefully before using the prefilled syringe. The opening of the sealed tray and all subsequent steps should be done under aseptic conditions. For the intravitreal injection, a 30-gauge × ½ inch sterile injection needle should be used (not provided).
Note: the dose must be set to 0.05 mL. Adequate anesthesia and a broad-spectrum microbicide should be given prior to the injection. Prior to and 30 minutes following the intravitreal injection, patients should be monitored for elevation in intraocular pressure using tonometry.
Monitoring may also consist of a check for perfusion of the optic nerve head immediately after the injection. Patients should also be monitored for and instructed to report any symptoms suggestive of endophthalmitis without delay following the injection. Each prefilled syringe should only be used for the treatment of a single eye.
If the contralateral eye requires treatment, a new prefilled syringe should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, and injection needle should be changed before LUCENTIS is administered to the other eye. No special dosage modification is required for any of the populations that have been studied (e.g., gender, elderly).
| Device description | |
| LUCENTIS prefilled syringes are available in 2 dose strengths: LUCENTIS 0.5 mg prefilled syringe with a CLEAR finger grip. | |
| LUCENTIS 0.3 mg prefilled syringe with an ORANGE finger grip. | |
| Check the labels on the LUCENTIS carton, syringe tray and prefilled syringe to make sure you have the correct dose strength. | |
| Step 1: Prepare | |
| Make sure that your pack contains a sterile prefilled syringe in a sealed tray. Peel the lid off the syringe tray and, using aseptic technique, remove the syringe. | |
| Step 2: Inspect syringe | |
| LUCENTIS should be colorless to pale yellow. Do not use the prefilled syringe if: - the syringe cap is detached from the Luer lock. - the syringe is damaged. - particulates, cloudiness, or discoloration are visible. | |
| Step 3: Remove syringe cap | |
| Snap off ( do not turn or twist) the syringe cap (see Figure 2 ). | |
| Step 4: Attach needle | |
| Attach a 30G × ½ inch sterile injection needle firmly onto the syringe by screwing it tightly onto the Luer lock (see Figure 3 ). Carefully remove the needle cap by pulling it straight off. Note: Do not wipe the needle at any time. | |
| Step 5: Dislodge air bubbles | |
| Hold the syringe with the needle pointing up. If there are any air bubbles, gently tap the syringe with your finger until the bubbles rise to the top (see Figure 4 ). | |
| Step 6: Expel air and adjust drug dose | |
| Hold the syringe at eye level, and carefully push the plunger rod until the edge below the dome of the rubber stopper is aligned with the 0.05 mL dose mark (see Figure 5 ). Note: The plunger rod is not attached to the rubber stopper – this is to prevent air being drawn into the syringe. | |
| Step 7: Inject | |
| The injection procedure should be carried out under aseptic conditions. Insert the needle into the injection site. Inject slowly until rubber stopper reaches the bottom of the syringe to deliver the volume of 0.05 mL. After injection, do not recap the needle or detach it from the syringe. Dispose of the used syringe together with the needle in a sharps disposal container or in accordance with local requirements. | |
Side Effects of Lucentis
Injection Procedure
Serious adverse reactions related to the injection procedure have occurred in < 0.1% of intravitreal injections, including endophthalmitis, rhegmatogenous retinal detachment, and iatrogenic traumatic cataract.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data below reflect exposure to 0.5 mg LUCENTIS in 440 patients with neovascular AMD in Studies AMD-1, AMD-2, and AMD-3; in 259 patients with macular edema following RVO. The data also reflect exposure to 0.3 mg LUCENTIS in 250 patients with DME and DR at baseline.
Safety data observed in 224 patients with mCNV, as well as Studies AMD-4 and D-3, were consistent with these results. On average, the rates and types of adverse reactions in patients were not significantly affected by dosing regimen. Ocular Reactions Table 1 shows frequently reported ocular adverse reactions in LUCENTIS-treated patients compared with the control group.
Table 1 Ocular Reactions in the DME and DR, AMD, and RVO Studies Non-Ocular Reactions Non-ocular adverse reactions with an incidence of ≥ 5% in patients receiving LUCENTIS for DR, DME, AMD, and/or RVO and which occurred at a ≥ 1% higher frequency in patients treated with LUCENTIS compared to control are shown in Table 2. Though less common, wound healing complications were also observed in some studies.
Immunogenicity As with all therapeutic proteins, there is the potential for an immune response in patients treated with LUCENTIS. The immunogenicity data reflect the percentage of patients whose test results were considered positive for antibodies to LUCENTIS in immunoassays and are highly dependent on the sensitivity and specificity of the assays. The pre-treatment incidence of immunoreactivity to LUCENTIS was 0%-5% across treatment groups.
After monthly dosing with LUCENTIS for 6 to 24 months, antibodies to LUCENTIS were detected in approximately 1%-9% of patients. The clinical significance of immunoreactivity to LUCENTIS is unclear at this time. Among neovascular AMD patients with the highest levels of immunoreactivity, some were noted to have iritis or vitritis.
Intraocular inflammation was not observed in patients with DME and DR at baseline, or RVO patients with the highest levels of immunoreactivity.
Postmarketing Experience
The following adverse reaction has been identified during post-approval use of LUCENTIS. Because this reaction was reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure. Ocular: Tear of retinal pigment epithelium among patients with neovascular AMD
| DME and DR 2-year | AMD 2-year | AMD 1-year | RVO 6-month | |||||
|---|---|---|---|---|---|---|---|---|
| Adverse Reaction | LUCENTIS 0.3 mg | Control | LUCENTIS 0.5 mg | Control | LUCENTIS 0.5 mg | Control | LUCENTIS 0.5 mg | Control |
| n=250 | n=250 | n=379 | n=379 | n=440 | n=441 | n=259 | n=260 | |
| Conjunctival hemorrhage | 47% | 32% | 74% | 60% | 64% | 50% | 48% | 37% |
| Eye pain | 17% | 13% | 35% | 30% | 26% | 20% | 17% | 12% |
| Vitreous floaters | 10% | 4% | 27% | 8% | 19% | 5% | 7% | 2% |
| Intraocular pressure increased | 18% | 7% | 24% | 7% | 17% | 5% | 7% | 2% |
| Vitreous detachment | 11% | 15% | 21% | 19% | 15% | 15% | 4% | 2% |
| Intraocular inflammation | 4% | 3% | 18% | 8% | 13% | 7% | 1% | 3% |
| Cataract | 28% | 32% | 17% | 14% | 11% | 9% | 2% | 2% |
| Foreign body sensation in eyes | 10% | 5% | 16% | 14% | 13% | 10% | 7% | 5% |
| Eye irritation | 8% | 5% | 15% | 15% | 13% | 12% | 7% | 6% |
| Lacrimation increased | 5% | 4% | 14% | 12% | 8% | 8% | 2% | 3% |
| Blepharitis | 3% | 2% | 12% | 8% | 8% | 5% | 0% | 1% |
| Dry eye | 5% | 3% | 12% | 7% | 7% | 7% | 3% | 3% |
| Visual disturbance or vision blurred | 8% | 4% | 18% | 15% | 13% | 10% | 5% | 3% |
| Eye pruritis | 4% | 4% | 12% | 11% | 9% | 7% | 1% | 2% |
| Ocular hyperemia | 9% | 9% | 11% | 8% | 7% | 4% | 5% | 3% |
| Retinal disorder | 2% | 2% | 10% | 7% | 8% | 4% | 2% | 1% |
| Maculopathy | 5% | 7% | 9% | 9% | 6% | 6% | 11% | 7% |
| Retinal degeneration | 1% | 0% | 8% | 6% | 5% | 3% | 1% | 0% |
| Ocular discomfort | 2% | 1% | 7% | 4% | 5% | 2% | 2% | 2% |
| Conjunctival hyperemia | 1% | 2% | 7% | 6% | 5% | 4% | 0% | 0% |
| Posterior capsule opacification | 4% | 3% | 7% | 4% | 2% | 2% | 0% | 1% |
| Injection site hemorrhage | 1% | 0% | 5% | 2% | 3% | 1% | 0% | 0% |
| DME and DR 2-year | AMD 2-year | AMD 1-year | RVO 6-month | |||||
|---|---|---|---|---|---|---|---|---|
| Adverse Reaction | LUCENTIS 0.3 mg | Control | LUCENTIS 0.5 mg | Control | LUCENTIS 0.5 mg | Control | LUCENTIS 0.5 mg | Control |
| n=250 | n=250 | n=379 | n=379 | n=440 | n=441 | n=259 | n=260 | |
| Nasopharyngitis | 12% | 6% | 16% | 13% | 8% | 9% | 5% | 4% |
| Anemia | 11% | 10% | 8% | 7% | 4% | 3% | 1% | 1% |
| Nausea | 10% | 9% | 9% | 6% | 5% | 5% | 1% | 2% |
| Cough | 9% | 4% | 9% | 8% | 5% | 4% | 1% | 2% |
| Constipation | 8% | 4% | 5% | 7% | 3% | 4% | 0% | 1% |
| Seasonal allergy | 8% | 4% | 4% | 4% | 2% | 2% | 0% | 2% |
| Hypercholesterolemia | 7% | 5% | 5% | 5% | 3% | 2% | 1% | 1% |
| Influenza | 7% | 3% | 7% | 5% | 3% | 2% | 3% | 2% |
| Renal failure | 7% | 6% | 1% | 1% | 0% | 0% | 0% | 0% |
| Upper respiratory tract infection | 7% | 7% | 9% | 8% | 5% | 5% | 2% | 2% |
| Gastroesophageal reflux disease | 6% | 4% | 4% | 6% | 3% | 4% | 1% | 0% |
| Headache | 6% | 8% | 12% | 9% | 6% | 5% | 3% | 3% |
| Edema peripheral | 6% | 4% | 3% | 5% | 2% | 3% | 0% | 1% |
| Renal failure chronic | 6% | 2% | 0% | 1% | 0% | 0% | 0% | 0% |
| Neuropathy peripheral | 5% | 3% | 1% | 1% | 1% | 0% | 0% | 0% |
| Sinusitis | 5% | 8% | 8% | 7% | 5% | 5% | 3% | 2% |
| Bronchitis | 4% | 4% | 11% | 9% | 6% | 5% | 0% | 2% |
| Atrial fibrillation | 3% | 3% | 5% | 4% | 2% | 2% | 1% | 0% |
| Arthralgia | 3% | 3% | 11% | 9% | 5% | 5% | 2% | 1% |
| Chronic obstructive pulmonary disease | 1% | 1% | 6% | 3% | 3% | 1% | 0% | 0% |
| Wound healing complications | 1% | 0% | 1% | 1% | 1% | 0% | 0% | 0% |
Warnings & Cautions for Lucentis
Endophthalmitis and Retinal Detachments
Intravitreal injections, including those with LUCENTIS, have been associated with endophthalmitis and retinal detachments. Proper aseptic injection technique should always be used when administering LUCENTIS. In addition, patients should be monitored following the injection to permit early treatment should an infection occur.
Increases in Intraocular Pressure Increases in intraocular pressure have been noted both pre-injection and post-injection (at 60 minutes) while being treated with LUCENTIS. Monitor intraocular pressure prior to and following intravitreal injection with LUCENTIS and manage appropriately.
Thromboembolic Events
Although there was a low rate of arterial thromboembolic events (ATEs) observed in the LUCENTIS clinical trials, there is a potential risk of ATEs following intravitreal use of VEGF inhibitors. Arterial thromboembolic events are defined as nonfatal stroke, nonfatal myocardial infarction, or vascular death (including deaths of unknown cause). In Study AMD-4, the ATE rates observed in the 0.5 mg arms during the first and second year were similar to rates observed in Studies AMD-1, AMD-2, and AMD-3.
Diabetic Macular Edema and Diabetic Retinopathy Safety data are derived from studies D-1 and D-2. All enrolled patients had DME and DR at baseline. At 3 years, the ATE rate was mg LUCENTIS and mg LUCENTIS; the stroke rate was mg LUCENTIS and mg LUCENTIS.
Although the rate of fatal events was low and included causes of death typical of patients with advanced diabetic complications, a potential relationship between these events and intravitreal use of VEGF inhibitors cannot be excluded.
Retinal Vasculitis with or without Occlusion
Retinal vasculitis with or without occlusion, typically in the presence of preexisting intraocular inflammation or post-treatment with other intravitreal agents, have been reported with the use of LUCENTIS. Discontinue treatment with LUCENTIS in patients who develop these events. Patients should be instructed to report any change in vision without delay.
Drug Interactions with Lucentis
Drug interaction studies have not been conducted with LUCENTIS. LUCENTIS intravitreal injection has been used adjunctively with PDT.
Pregnancy Safety for Lucentis
Pregnancy Risk Summary There are no adequate and well-controlled studies of LUCENTIS administration in pregnant women. Administration of ranibizumab to pregnant monkeys throughout the period of organogenesis resulted in a low incidence of skeletal abnormalities at intravitreal doses 13-times the predicted human exposure (based on maximal serum trough levels ) after a single eye treatment at the recommended clinical dose. No skeletal abnormalities were observed at serum trough levels equivalent to the predicted human exposure after a single eye treatment at the recommended clinical dose.
Animal reproduction studies are not always predictive of human response, and it is not known whether ranibizumab can cause fetal harm when administered to a pregnant woman. Based on the anti-VEGF mechanism of action for ranibizumab, treatment with LUCENTIS may pose a risk to human embryofetal development. LUCENTIS should be given to a pregnant woman only if clearly needed.
Data Animal Data An embryo-fetal developmental toxicity study was performed on pregnant cynomolgus monkeys. Skeletal abnormalities including incomplete and/or irregular ossification of bones in the skull, vertebral column, and hindlimbs and shortened supernumerary ribs were seen at a low incidence in fetuses from animals treated with 1 mg/eye of ranibizumab. The 1 mg/eye dose resulted in trough serum ranibizumab levels up to 13 times higher than predicted C max levels with single eye treatment in humans.
No skeletal abnormalities were seen at the lower dose of 0.125 mg/eye, a dose which resulted in trough exposures equivalent to single eye treatment in humans. No effect on the weight or structure of the placenta, maternal toxicity, or embryotoxicity was observed.
Pediatric Use of Lucentis
Pediatric Use The safety and effectiveness of LUCENTIS in pediatric patients have not been established.
Contraindications for Lucentis
Ocular or Periocular Infections LUCENTIS is contraindicated in patients with ocular or periocular infections.
Hypersensitivity LUCENTIS is contraindicated in patients with known hypersensitivity to ranibizumab or any of the excipients in LUCENTIS. Hypersensitivity reactions may manifest as severe intraocular inflammation.
Overdosage Information for Lucentis
More concentrated doses as high as 2 mg ranibizumab in 0.05 mL have been administered to patients. No additional unexpected adverse reactions were seen.
Clinical Studies of Lucentis
Neovascular (Wet) Age-Related Macular Degeneration (AMD)
The safety and efficacy of LUCENTIS were assessed in three randomized, double-masked, sham- or active-controlled studies in patients with neovascular AMD. A total of 1323 patients (LUCENTIS 879, control 444) were enrolled in the three studies. Studies AMD-1 and AMD-2 In Study AMD-1, patients with minimally classic or occult (without classic) CNV lesions received monthly LUCENTIS 0.3 mg or 0.5 mg intravitreal injections or monthly sham injections.
Data are available through Month 24. In Study AMD-2, patients with predominantly classic CNV lesions received one of the following: 1 monthly LUCENTIS 0.3 mg intravitreal injections and sham PDT; 2 monthly LUCENTIS 0.5 mg intravitreal injections and sham PDT; or 3 sham intravitreal injections and active PDT. Sham PDT (or active PDT) was given with the initial LUCENTIS (or sham) intravitreal injection and every 3 months thereafter if FA showed persistence or recurrence of leakage.
In both studies, the primary efficacy endpoint was the proportion of patients who maintained vision, defined as losing fewer than 15 letters of visual acuity at 12 months compared with baseline. Almost all LUCENTIS-treated patients (approximately 95%) maintained their visual acuity. The size of the lesion did not significantly affect the results.
Detailed results are shown in Table 3, Table 4, and Figure 1 below. At Month 12, the mean change in the total area of the CNV lesion was 0.1-0.3 disc areas (DA) for LUCENTIS versus 2.3-2.6 DA for the control arms. At Month 24, the mean change in the total area of the CNV lesion was 0.3-0.4 DA for LUCENTIS versus 2.9-3.1 DA for the control arms.
Figure 1 Study AMD-3 Study AMD-3 was a randomized, double-masked, sham-controlled, 2-year study designed to assess the safety and efficacy of LUCENTIS in patients with neovascular AMD (with or without a classic CNV component). Data are available through Month 12. Patients treated with LUCENTIS in Study AMD-3 received a mean of six total treatments out of a possible 6 from Day 0 through Month 12.
In Study AMD-3, the primary efficacy endpoint was the mean change in visual acuity at 12 months compared with baseline (see Figure 2 ). After an initial increase in visual acuity (following monthly dosing), on average, patients dosed once every 3 months with LUCENTIS lost visual acuity, returning to baseline at Month 12. In Study AMD-3, almost all LUCENTIS-treated patients (90%) lost fewer than 15 letters of visual acuity at Month 12.
Figure 2 Mean Change in Visual Acuity from Baseline to Month 12 in Study AMD-3 Figure 2 Study AMD-4 Study AMD-4 was a randomized, double-masked, active treatment-controlled, two-year study designed to assess the safety and efficacy of LUCENTIS 0.5 mg administered monthly or less frequently than monthly in patients with neovascular AMD. Patients randomized to the LUCENTIS 0.5 mg less frequent dosing arm received three monthly doses followed by monthly assessments where patients were eligible to receive LUCENTIS injections guided by pre-specified re-treatment criteria. The distribution of injections received in the less frequent dosing arm is shown in Figure 4.
Figure 3 Figure 4
Macular Edema Following Retinal Vein Occlusion (RVO)
The safety and efficacy of LUCENTIS were assessed in two randomized, double-masked, 1-year studies in patients with macular edema following RVO. Sham controlled data are available through Month 6. Patient age ranged from 20 to 91 years, with a mean age of 67 years.
All patients completing Month 6 were eligible to receive LUCENTIS injections guided by pre-specified re-treatment criteria until the end of the studies at Month 12. In Study RVO-1, patients with macular edema following branch or hemi-RVO, received monthly LUCENTIS 0.3 mg or 0.5 mg intravitreal injections or monthly sham injections for 6 months. All patients were eligible for macular focal/grid laser treatment beginning at Month 3 of the 6-month treatment period.
All enrolled patients had DR and DME at baseline. The studies were sham-controlled through Month 24. Patient age ranged from 21 to 91 years, with a mean age of 62 years.
In Studies D-1 and D-2, patients received monthly LUCENTIS 0.3 mg or 0.5 mg intravitreal injections or monthly sham injections during the 24-month controlled treatment period. Compared to monthly LUCENTIS 0.3 mg, no additional benefit was observed with monthly treatment with LUCENTIS 0.5 mg. At Month 24, after monthly treatment with LUCENTIS 0.3 mg, the following clinical results were observed: Table 6 Visual Acuity Outcomes at were maintained with continued treatment through Month 36 in both DME studies.
Patients in the sham arms who received LUCENTIS 0.5 mg beginning at Month 25 achieved lesser VA gains compared to patients who began treatment with LUCENTIS at the beginning of the studies. In Studies D-1 and D-2, patients received monthly injections of LUCENTIS for 12 or 36 months, after which 500 patients opted to continue in the long-term follow-up study. The remaining 202 patients were followed for less than 12 months.
Figure 6
Diabetic Retinopathy (DR) Efficacy and safety data of LUCENTIS are derived from Studies D-1 and D-2 and D-3. Study D-3 enrolled DR patients both with and without DME at baseline. Of the 759 patients enrolled in Studies D-1 and D-2, 746 patients had a baseline assessment of fundus photography.
Patients had baseline Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scores (ETDRS-DRSS) ranging from 10 to 75. The ETDRS-DRSS could not be graded in 5% of patients at baseline, and 2% of patients had absent or questionable DR at baseline. Approximately 20% of the overall population had prior PRP.
After monthly treatment with LUCENTIS 0.3 mg, the following clinical results were observed ( Table 7; Figure 7 ): Table 7 ≥3-Step and ≥2-Step Improvement at, DR improvement by ≥3-steps in ETDRS-DRSS from baseline in subgroups examined (e.g., age, gender, race, baseline visual acuity, baseline HbA1c, prior DME therapy at baseline, baseline DR severity (NPDR, PDR)) were generally consistent with the results in the overall population. The difference in the proportion of patients treated with LUCENTIS 0.3 mg compared to sham who achieved DR improvement based on the ETDRS-DRSS was observed as early as Study D-3 enrolled DR patients with and without DME; 88 (22%) eyes with baseline DME and 306 (78%) eyes without baseline DME and balanced across treatment groups. Study D-3 was a randomized, active-controlled study where patient age ranged from 20 to 83 with a mean age of 51 years.
All eyes in the LUCENTIS group received a baseline 0.5 mg intravitreal injection followed by 3 monthly intravitreal injections, after which treatment was guided by pre-specified re-treatment criteria. Patients had baseline ETDRS-DRSS ranging from 20 to 85. An analysis of data from Study D-3 demonstrated that at Year 2 in the LUCENTIS group, 31.7% and 28.4% of eyes in the subgroups with baseline DME and without baseline DME, respectively, had ≥ 3-step improvement from baseline in ETDRS-DRSS.
Table 8 Proportion of Eyes with ≥ 3-Step and ≥ 2-Step Improvement from Baseline in ETDRS-DRSS at Year 2 in Study D-3 Myopic Choroidal Neovascularization (mCNV) The efficacy and safety data of LUCENTIS were assessed in a randomized, double-masked, active-controlled 3-month study in patients with mCNV. Patients age ranged from 18 to 87 years, with a mean age of 55 years. A total of 276 patients (222 patients in the LUCENTIS treated Groups I and II; 55 patients in the active control PDT group) were enrolled.
The retreatment criteria in Group I were vision stability guided, with the Best Corrected Visual Acuity (BCVA) at the current visit being assessed for changes compared with the two preceding monthly BCVA values. The retreatment criteria in Group II were disease activity guided, based on BCVA decrease from the previous visit that was attributable to intra- or sub-retinal fluid or active leakage secondary to mCNV as assessed by OCT and/or FA compared to the previous monthly visit. Visual gains for the two LUCENTIS 0.5 mg treatment arms were superior to the active control arm.
Efficacy was comparable between Group I and Group II. Figure 9
| Outcome Measure | Month | Sham n=229 | LUCENTIS 0.5 mg n=230 | Estimated Difference (95% CI) Adjusted estimate based on the stratified model; p < 0.01 |
|---|---|---|---|---|
| Loss of <15 letters in visual acuity (%) | 12 | 60% | 91% | 30% (23%, 37%) |
| 24 | 56% | 89% | 33% (26%, 41%) | |
| Gain of ≥15 letters in visual acuity (%) | 12 | 6% | 31% | 25% (18%, 31%) |
| 24 | 4% | 30% | 25% (18%, 31%) | |
| Mean change in visual acuity (letters) (SD) | 12 | -11.0 (17.9) | +6.3 ( 14.1) | 17.1 (14.2, 20.0) |
| 24 | -15.0 (19.7) | +5.5 ( 15.9) | 20.1 (16.9, 23.4) |
| Outcome Measure | Month | PDT n=141 | LUCENTIS 0.5 mg n=139 | Estimated Difference (95% CI) Adjusted estimate based on the stratified model; p < 0.01 |
|---|---|---|---|---|
| Loss of <15 letters in visual acuity (%) | 12 | 66% | 98% | 32% (24%, 40%) |
| 24 | 65% | 93% | 28% (19%, 37%) | |
| Gain of ≥15 letters in visual acuity (%) | 12 | 11% | 37% | 26% (17%, 36%) |
| 24 | 9% | 37% | 29% (20%, 39%) | |
| Mean change in visual acuity (letters) (SD) | 12 | -8.5 (17.8) | +11.0 (15.8) | 19.8 (15.9, 23.7) |
| 24 | -9.1 (18.7) | +10.9 (17.3) | 20 (16.0, 24.4) |
| Outcome Measure | Study RVO-1: Sham, n=131; LUCENTIS 0.5 mg, n=132 RVO-2: Sham, n=130; LUCENTIS 0.5 mg, n=130 | Sham | LUCENTIS 0.5 mg | Estimated Difference (95% CI) Adjusted estimate based on stratified model; p < 0.01 |
|---|---|---|---|---|
| Gain of ≥15 letters in visual acuity (%) | RVO-1 | 29% | 61% | 31% (20%, 43%) |
| Gain of ≥15 letters in visual acuity (%) | RVO-2 | 17% | 48% | 30% (20%, 41%) |
| Outcome Measure | Study D-1: Sham, n=130; LUCENTIS 0.3 mg, n=125 D-2: Sham, n=127; LUCENTIS 0.3 mg, n=125 | Sham | LUCENTIS 0.3 mg | Estimated Difference (95% CI) Adjusted estimate based on stratified model; p ≤ 0.01 |
|---|---|---|---|---|
| Gain of ≥15 letters in visual acuity (%) | D-1 | 12% | 34% | 21% (11%, 30%) |
| D-2 | 18% | 45% | 24% (14%, 35%) | |
| Loss of <15 letters in visual acuity (%) | D-1 | 92% | 98% | 7% (2%, 13%) |
| D-2 | 90% | 98% | 8% (2%, 14%) | |
| Mean change in visual acuity (letters) | D-1 | 2.3 | 10.9 | 8.5 (5.4, 11.5) |
| D-2 | 2.6 | 12.5 | 9.6 (6.1, 13.0) |
| Outcome Measure | Study D-1: Sham, n=124; LUCENTIS 0.3 mg, n=117 D-2: Sham, n=115; LUCENTIS 0.3 mg, n=117 | Sham | LUCENTIS 0.3 mg | Estimated Difference (95% CI) Adjusted estimate based on stratified model |
|---|---|---|---|---|
| ≥3-step improvement from baseline in ETDRS-DRSS p < 0.05 for all time points comparing LUCENTIS 0.3 mg to sham from Month 12 through Month 24 | D-1 | 2% | 17% | 15% (7%, 22%) |
| D-2 | 0% | 9% | 9% (4%, 14%) | |
| ≥2-step improvement from baseline in ETDRS-DRSS p < 0.05 for all time points comparing LUCENTIS 0.3 mg to sham from Month 3 through Month 24 | D-1 | 4% | 39% | 35% (26%, 44%) |
| D-2 | 7% | 37% | 31% (21%, 40%) |
| Figure 7 Proportion of Patients with ≥ 3-Step and ≥ 2-Step Improvement from Baseline in ETDRS Diabetic Retinopathy Severity Level over Time in Study D-1 and Study D-2 | |||
| ≥3-Step Improvement from Baseline Over Time | ≥2-Step Improvement from Baseline Over Time | ||
| LUCENTIS group | ||
|---|---|---|
| Outcome Measure (in ETDRS-DRSS) | Eyes with Baseline DME n = 41 | Eyes without Baseline DME n = 148 |
| ≥ 3-step improvement from baseline 95% CI for percentage | 13 (31.7%) (17.5%, 46.0%) | 42 (28.4%) (21.1%, 35.6%) |
| ≥ 2-step improvement from baseline 95% CI for percentage | 24 (58.5%) (43.5%, 73.6%) | 56 (37.8%) (30.0%, 45.7%) |
| Study Arms | Mean change in BCVA from baseline (Letters) | Proportion of patients who gained ≥15 letters from baseline | ||
|---|---|---|---|---|
| Mean (SD) | Estimated Difference (95% CI) Adjusted estimates based on stratified models; p < 0.01 | Percent | Estimated Difference (95% CI) | |
| Group I | 12.1 (10.2) | 10.9 (7.6, 14.3) | 37.1 | 22.6 (9.5, 35.7) |
| Group II | 12.5 (8.8) | 11.4 (8.3, 14.5) | 40.5 | 26.0 (13.1, 38.9) |
| Control (PDT) | 1.4 (12.2) | 14.5 | ||
Drug information sourced from the FDA. This content is for informational purposes only and does not constitute medical advice. Consult a healthcare professional before making any medication decisions.
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