Ranibizumab for Macular Edema Secondary to Branch Retinal Vein Occlusion in Patients With Fair Vision

Macular Edema Clinical Trial

— RVOFV  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01795209
• Other study ID #: B-1207-162-005
• Secondary ID: B-1207-162-005
• Status: Terminated
• Phase: Phase 4
• Start date: January 2013
• Est. completion date: December 2017

Study information

• Verified date: September 2019
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Branch Retinal Vein Occlusion
• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• Ranibizumab
Loading dose: three monthly intravitreal injections of ranibizumab 0.5 mg Lucentis stop criteria: V/A =20/20 and complete disappearance of macular edema Retreatment: visual loss of 5 or more letter compared to previous visit

Device:
• Sham injection
Three monthly sham injections followed by retreatment (sham injections) as needed Stop criteria: V/A =20/20 and complete disappearance of macular edema Retreatment: visual loss of 5 or more letter compared to previous visit

Procedure:
• Rescue laser
In the Lucentis group: performed if BCVA < 20/40 or CFT = 350um despite of 3 sessions of previous Lucenis injection from Month 6 In the standard of care group: performed if BCVA < 20/40 or CFT = 350um from Month 3

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyunggi-do
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Novartis, Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

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

Outcome

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