Macular Edema Clinical Trial
— RVOFVOfficial 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
Verified date | September 2019 |
Source | Seoul National University Bundang Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 19 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang Hospital | Seongnam | Gyunggi-do |
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Bundang Hospital | Novartis, Samsung Medical Center |
Korea, Republic of,
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to achieve an improvement of 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters in best-corrected visual acuity | 1 year | ||
Secondary | Mean change from baseline ETDRS letter score over time | 6 months and 1 year | ||
Secondary | Percentage of patients gaining 10 or more letters in ETDRS letter score from baseline BCVA | 6 months and 1 year | ||
Secondary | Percentage of patients gaining < 10 letters in ETDRS letter score from baseline BCVA | 6 months and 1 year | ||
Secondary | Percentage of patients losing < 10 letters in ETDRS letter score from baseline BCVA | 6 months and 1 year | ||
Secondary | Proportion of patients with who at least maintain baseline BCVA | 6 months and 1 year | ||
Secondary | Percentage of patients with central foveal thickness (CFT) of < 300 um | 6 months and 1 year | ||
Secondary | Safety outcomes | Frequency, type, and severity of adverse reactions | 6 months and 1 year | |
Secondary | Mean change from baseline CFT over time | 6 months and 1 year | ||
Secondary | Mean change from baseline in National Eye Institute Visual Function Questionnaire-25 (NEI-VFQ-25) distance activities subscale score | 6 months and 1 year | ||
Secondary | Mean change from baseline in contrast sensitivity | 6 months and 1 year | ||
Secondary | Mean change from baseline in multifocal electroretinogram (mfERG) P1 amplitude | 6 months and 1 year | ||
Secondary | Percentage of patients losing 10 or more letters in ETDRS letter score from baseline BCVA | 6 months and 1 year |
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