Clinical trial NCT01795209: Ranibizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion in Patients With Fair Vision
Official title: Phase 4 Study of Ranibizumab for the Treatment of Visual Impairment Due to Macular Edema Secondary to Branch Retinal Vein Occlusion in Patients With Initial Fair Visual Acuity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Branch Retinal Vein Occlusion
Macular Edema
Keywords: Branch retinal vein occlusion
Macular edema
Ranibizumab
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Samsung Medical Center
name: Novartis
First posted: 2013-02-20
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of ranibizumab for the treatment of macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in patients with initial fair visual acuity.

Detailed description: Lucentis was approved for ME due to BRVO based on the results from BRAVO study. The inclusion criteria in BRAVO was "best corrected visual acuity (BCVA) 20/40 to 20/320". Therefore, the patients with VA better than 20/40 who are out of inclusion criteria of BRAVO study had no treatment and just wait to reach spontaneous improvement. But, there is unmet needs of these patients and, in actual clinical practice, many retina specialists treat these patients with Ranibizumab. These patients have been experiencing VA improvement after the injection. Based on these clinical backgrounds, the investigator wants to suggest the treatment guidelines in these patients group, which is, early treatment of ranibizumab would be effective and increase patients' QOL. In other words, there are many experiences in these cases among ophthalmologists, but there have been no clinical trials that can endorse the treatments. To confirm the efficacy of ranibizumab in patients with initial fair vision, the investigators started the prospective randomized clinical trial on the efficacy and safety of ranibizumab for the patients.

Eligibility criteria: Inclusion Criteria:

1. Foveal center-involving macular edema secondary to BRVO diagnosed within 12 months before study enrollment
2. ETDRS chart BCVA: 63 to 77 letters (20/32 to 20/50 Snellen equivalent)
3. CFT \>= 300 um (mean of measurements obtained at screening and Day 0)
4. Signed consent informed
5. male or female, age ≥18 years old

Exclusion Criteria:

1. Prior episode of RVO: Past history of RVO in the study eye diagnosed before 1 year of study enrollment.
2. BCVA improvement \>10 letters between screening and Day 0
3. History of other ocular diseases (e.g. diabetic retinopathy, age-related macular degeneration)
4. Laser treatment within 3 months before baseline
5. Intraocular corticosteroid use within 3 months before baseline
6. Anti-vascular endothelial growth factor (VEGF) treatment in the study or fellow eye within 3 months before baseline
7. Intraocular surgery other than cataract surgery, Cataract surgery within 6 months before baseline
8. Stroke or myocardial infarction ≤3 months before baseline
9. Pregnancy or plan to have baby in female

Primary outcomes:
measure: Time to achieve an improvement of 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best-corrected visual acuity
timeFrame: 1 year
Secondary outcomes:
measure: Mean change from baseline ETDRS letter score over time
timeFrame: 6 months and 1 year
measure: Percentage of patients gaining 10 or more letters in ETDRS letter score from baseline BCVA
timeFrame: 6 months and 1 year
measure: Percentage of patients gaining < 10 letters in ETDRS letter score from baseline BCVA
timeFrame: 6 months and 1 year
measure: Percentage of patients losing < 10 letters in ETDRS letter score from baseline BCVA
timeFrame: 6 months and 1 year
measure: Proportion of patients with who at least maintain baseline BCVA
timeFrame: 6 months and 1 year
measure: Percentage of patients with central foveal thickness (CFT) of < 300 um
timeFrame: 6 months and 1 year
measure: Safety outcomes
timeFrame: 6 months and 1 year
measure: Mean change from baseline CFT over time
timeFrame: 6 months and 1 year
measure: Mean change from baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) distance activities subscale score
timeFrame: 6 months and 1 year
measure: Mean change from baseline in contrast sensitivity
timeFrame: 6 months and 1 year
measure: Mean change from baseline in multifocal electroretinogram (mfERG) P1 amplitude
timeFrame: 6 months and 1 year
measure: Percentage of patients losing 10 or more letters in ETDRS letter score from baseline BCVA
timeFrame: 6 months and 1 year
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyunggi-do
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Seoul National Univeristy Bundang Hospital
name: Kyu Hyung Park, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Samsung Medical Center
name: Se Woong Kang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Campochiaro PA, Heier JS, Feiner L, Gray S, Saroj N, Rundle AC, Murahashi WY, Rubio RG; BRAVO Investigators. Ranibizumab for macular edema following branch retinal vein occlusion: six-month primary end point results of a phase III study. Ophthalmology. 2010 Jun;117(6):1102-1112.e1. doi: 10.1016/j.ophtha.2010.02.021. Epub 2010 Apr 15.