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Ranibizumab

Angiogenesis Inhibitors

Growth Inhibitors

As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection

Ranibizumab 0.5 mg

Sham injection

Novartis Pharmaceuticals

Provided efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to BRVO

Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Branch Retinal Vein Occlusion (BRVO)

A Randomized Double-masked, Phase III Study Assessing Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Visual Impairment Due to Macular Edema (ME) Secondary to Branch Retinal Vein Occlusion (BRVO) [Blossom]

Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 6 and compared to Baseline.

Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. Mean Visual Acuity was averaged over all monthly assessments from month 1 to month 12 and compared to Baseline

Best Corrected Visual Acuity (BCVA) was assessed in a sitting position using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters

Visual acuity (VA) was assessed at every study visit using best correction determined from protocol refraction. VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity testing charts at a testing distance of 4 meters. This outcome measure describes for each post-baseline month whether or not a patient lost less than 15 letters of VA as compared with baseline.

OCT (optical coherence tomography) was used to assess CSFT (Central Sub-Field Thickness) representing the average retinal thickness of the circular area within 1 mm diameter around the foveal center

Fluorescein leakage area was assessed using Fluorescein angiography (FA) in conjunction with 7-field color fundus photography (CF) at Screening, Month 3, Month 6 and End of Study visit for both eyes

The VFQ-25 consists of 25 vision related questions across 11 vision related subscales, including general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision and peripheral vision, and a general health rating. Items are converted to a 0-100 scale on each subscale and for the composite score where higher scores represents better functioning.

The Safety Set consisted of all patients who received at least one application of study treatment and had at least one post-Baseline safety assessment. Patients were analyzed according to the treatment received. The statement that a patient had no AEs also constituted a safety assessment.

Sham With Ranibizumab 0.5 mg

sham + ranibizumab 0.5 mg PRN as of Month 6 (hereafter referred to as sham group up to Month 6 and sham with ranibizumab or sham without ranibizumab after Month 6)

Sham Without Ranibizumab 0.5 mg

Sham Injection

Total

Age, Continuous

Sex: Female, Male

One patient was randomized to the ranibizumab group but received no study treatment during the study period and discontinued the study after Visit 2. Therefore, excluded from the Safety set

Study Director

The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. Mean value interpolation and last observation carried forward (MV-LOCF)

Average Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 1 Through Month 6

Average Change of Best Corrected Visual Acuity (BCVA) in Patients From Baseline to Month 1 Through Month 12

Month 1

Month 2

Month 3

Month 4

Month 5

Month 6

Month 7

Month 8

Month 9

Month 10

Month 11

Month 12

Best Corrected Visual Acuity (BCVA) Change Over Time

Month 1 Gain of >=5 letters

Month 1 Gain of >=10 letters

Month 1 Gain of >=15 letters

Month 1 Gain of >=30 letters

Month 2 Gain of >=5 letters

Month 2 Gain of >=10 letters

Month 2 Gain of >=15 letters

Month 2 Gain of >=30 letters

Month 3 Gain of >=5 letters

Month 3 Gain of >=10 letters

Month 3 Gain of >=15 letters

Month 3 Gain of >=30 letters

Month 4 Gain of >=5 letters

Month 4 Gain of >=10 letters

Month 4 Gain of >=15 letters

Month 4 Gain of >=30 letters

Month 5 Gain of >=5 letters

Month 5 Gain of >=10 letters

Month 5 Gain of >=15 letters

Month 5 Gain of >=30 letters

Month 6 Gain of >=5 letters

Month 6 Gain of >=10 letters

Month 6 Gain of >=15 letters

Month 6 Gain of >=30 letters

Month 7 Gain of >=5 letters

Month 7 Gain of >=10 letters

Month 7 Gain of >=15 letters

Month 7 Gain of >=30 letters

Month 8 Gain of >=5 letters

Month 8 Gain of >=150 letters

Month 8 Gain of >=15 letters

Month 8 Gain of >=30 letters

Month 9 Gain of >=5 letters

Month 9 Gain of >=10 letters

Month 9 Gain of >=15 letters

Month 9 Gain of >=30 letters

Month 10 Gain of >=5 letters

Month 10 Gain of >=10 letters

Month 10 Gain of >=15 letters

Month 10 Gain of >=30 letters

Month 11 Gain of >=5 letters

Month 11 Gain of >=10 letters

Month 11 Gain of >=15 letters

Month 11 Gain of >=30 letters

Month 12 Gain of >=5 letters

Month 12 Gain of >=10 letters

Month 12 Gain of >=15 letters

Month 12 Gain of >=30 letters

Number of Participants With a Best Corrected Visual Acuity (BCVA) Improvement of ≥5, ≥10, ≥15, and ≥30 Letters Over Time

Month 1, Loss of < 15 letters

Month 2, Loss of < 15 letters

Month 3, Loss of < 15 letters

Month 4, Loss of < 15 letters

Month 5, Loss of < 15 letters

Month 6, Loss of < 15 letters

Month 7, Loss of < 15 letters

Month 8, Loss of < 15 letters

Month 9, Loss of < 15 letters

Month 10, Loss of < 15 letters

Month 11, Loss of < 15 letters

Month 12, Loss of < 15 letters

Number of Participants With Best Corrected Visual Acuity (BCVA)Loss of 15 Letters in the Study Eye

Change in Central-Sub-Field- Thickness (CSFT) Over Time

Change in Total Area of Fluorescein Leakage (Center Subfield) From Baseline Over Time

Change in Total Area of Fluorescein Leakage (Inner Subfield) From Baseline Over Time

Change in Total Area of Fluorescein Leakage (Outer Subfield) From Baseline Over Time

Change from Baseline at M3 (n=187,91)

Change from Baseline at M6 (n=185,88)

Change from Baseline at M12 (n=176,88)

The Full Analysis Set (FAS) consisted of all patients to whom study treatment had been assigned. Following the intent-to-treat principle, patients were analyzed according to the treatment group they had been assigned to at randomization. n=the number of patients with a value for both baseline and the specific post-baseline visit.

Change From Baseline in NEI-VFQ-25 Composite and Subscale Scores at Month 3, Month 6 and Month 12

Overall Study

Neovascularization, Pathologic

Choroidal Neovascularization

Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months.

Ranibizumab intravitreal injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year).

Phillip Lai, M.D.

This is an open-label, multicenter, extension study of intravitreally administered ranibizumab in two cohorts. The first cohort (reported separately under FVF3426g, NCT00379795) enrolled subjects with primary or recurrent Choroidal Neovascularization (CNV) secondary to Age-Related Macular Degeneration (AMD) who completed the treatment phase of a Genentech sponsored study (FVF2598g (NCT00056836), FVF2587g (NCT00061594), or FVF2428g (NCT00056823)). The second cohort (reported here) enrolled subjects with macular edema secondary to Retinal Vein Occlusion (RVO) who completed the 6-month treatment and 6-month observation phases (12 months total) of a Genentech sponsored study (FVF4165g (NCT00486018) or FVF4166g (NCT00485836)). Patients were enrolled within 14 days of completion of the previous study.

An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)

An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) or Macular Edema Secondary to Retinal Vein Occlusion (RVO) Who Have Completed a Genentech-Sponsored Ranibizumab Study

Number of participants with: any ocular adverse events, ocular adverse events causing treatment discontinuation, ocular serious adverse events, intraocular inflammation and cataracts that occurred in the study eye.

Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.

Number of participants with non-ocular adverse events (not occurring in the eye) in the following categories: any adverse events, serious adverse events, adverse events leading to study discontinuation and death.

Only adverse events that occurred during this extension study are reported. For subjects in the crossover groups who started their first ranibizumab injection in this extension study, adverse events that occurred prior to any ranibizumab injection were also excluded.

Additional information about adverse events can be found in the adverse events section.

Change from baseline in then BCVA was assessed by the number of letters a patient could read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) Eye Chart at a Starting Test Distance of 4 Meters. An increase in the number of letters read indicates improvement in visual acuity.

Change from baseline in Central foveal (retinal) thickness was assessed by Optical Coherence Tomography (OCT). OCT was conducted at the study sites by personnel who were certified by the University of Wisconsin Fundus Photograph Reading Center.

NEI VFQ-25 is a 25 item questionnaire that assesses visual function and quality of life for a total possible score of 0 to 100. A higher score represents better functioning. The change from baseline is calculated at Month 12 and Month 24.

Participants are grouped according to the treatment they received in initial studies FVF4165g BRAVO (NCT00486018) and FVF4166g CRUISE (NCT00485836).

Genentech, Inc.

Safety Population included all participants who received at least one dose of study drug in one of the initial studies or this extension study. These analyses include only those adverse events that occurred during this extension study.

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE and received Ranibizumab during the 6 month observation period of the initial study or this extension study.

Ranibizumab (Sham)

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE.

Ranibizumab (0.3 mg)

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE.

Ranibizumab (0.5 mg)

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.

Ranibizumab (Sham BRAVO)

In this extension study participant received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.

Ranibizumab (0.3 mg BRAVO)

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.

Ranibizumab (0.5 mg BRAVO)

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.

Ranibizumab (Sham CRUISE)

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.

Ranibizumab (0.3 mg CRUISE)

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.

Ranibizumab (0.5 mg CRUISE)

<45 years

45 to <65 years

65 to <85 years

≥85 years

Age, Customized

Genentech

Any ocular adverse event (AE)

Ocular AE leading to treatment discontinuation

Ocular serious adverse event

Intraocular inflammation

Cataract

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.

In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.

Ranibizumab- Treated Participants includes all participants who received Ranibizumab in one of the initial studies or this extension study. This analysis includes only those adverse events that occurred during this extension study.

Number of Participants With Ocular Adverse Events in the Study Eye

Any non-ocular adverse event

Serious non-ocular adverse event

Non-ocular adverse event led to discontinuation

Death

Number of Participants With Non-ocular Adverse Events

Month 6 (n=88,96,98,90,101,91)

Month 12 (n=66,66,73,58,69,50)

Month 18 (n=23,26,32,31,26,22)

Month 24 (n=0,2,0,0,1,0)

Enrolled participants for whom data was available for analyses at the given time-points. Observed data were used with no imputation. The number of participants for whom data was available for analyses is represented by "n".

Change From Baseline in the Best Corrected Visual Acuity (BCVA)

Month 6 (n=86,96,97,90,101,89)

Month 12 (n=62,65,72,56,69,51)

Enrolled participants for whom data was available for analyses at the given time-point as indicated by "n" in the categories. Observed data were used with no imputation.

Change From Baseline in Central Foveal Thickness at Month 6 and Month 12

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Branch Retinal Vein Occlusion (BRVO)	NCT01976338	Macular Edema S...	Ranibizumab 0.5... Sham injection	18 Years -	Novartis
An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)	NCT01442064	Macular Edema Retinal Vein Oc...	Ranibizumab 0.5...	18 Years -	Genentech, Inc.
An Extension Study to Evaluate Safety and Tolerability of Ranibizumab in Macular Edema Secondary to Retinal Vein Occlusion (Cohort 2)	NCT01442064	Macular Edema Retinal Vein Oc...	Ranibizumab 0.5...	18 Years -	Genentech, Inc.
Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Branch Retinal Vein Occlusion (BRVO)	NCT01976338	Macular Edema S...	Ranibizumab 0.5... Sham injection	18 Years -	Novartis
Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Branch Retinal Vein Occlusion (BRVO)	NCT01976338	Macular Edema S...	Ranibizumab 0.5... Sham injection	18 Years -	Novartis
Efficacy and Safety of Ranibizumab 0.5 vs Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia	NCT01922102	Visual Impairme...	Ranibizumab 0.5... Ranibizumab 0.5... Verteporfin PDT	18 Years -	Novartis

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