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Edema

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Vision, Low

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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

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
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

Spots Global Cancer Trial Database for macular edema secondary to branch retinal vein occlusion