Comparative evaluation of branch retinal vein occlusion treatment with ultra wide-field imaging guided peripheral scatter laser in combination with ranibizumab ( anti-VEGF for macular edema in BRVO) vs ranibizumab only in treatment naive cases.

Completed

• Conditions: BRVO with macular edema

• Registration Number: CTRI/2018/03/012383
• Lead Sponsor: AIIMS

Brief Summary

Branch retinal vein occlusion is a leading cause of vision loss. Treatment with ranibizumab (vascular endothelial growth factor (VEGF) inhibitor) on a monthly basis has been associated with improved vision results. There is a subgroup of patients with peripheral nonperfusion on ultrawidefield angiography that appears to be more dependent on anti-VEGF treatment.

In this trial the investigators compare the gold standard of monthly ranibizumab injections with ranibizumab + peripheral scatter laser to the areas of nonperfusion on angiography. Each group will have monthly injections for the first 3 months, then as needed by either visual acuity decrease or increased retinal thickness for the subsequent 3 months.

The primary outcome is visual acuity. Secondary outcomes are reduction in optical coherence tomography, and number of ranibizumab injections

The purpose of the study is to assess whether peripheral scatter laser has any role in decreasing the macular edema in BRVO patients in addition to anti-VEGF ( Ranibizumab ). 

Ultrawidefield FA reveals correlation between non perfusion in the peripheral retina with macular edema and retinal neovascularisation. The study hypothesis is to determine if laser photocoagulation of the non perfused retina decreases macular edema and neovascularisation.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-07-10
• Study Completion: 2016-09-30
• Last Update Posted: 2018-02-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1.Diagnosed case of BRVO with macular edema with evidence of capillary non perfusion 2.Macular edema involving center of fovea 3.BCVA at baseline- 3/60-6/18 by Snellen’s visual acuity 4.Mean central subfield thickness > 300 micrometer by OCT at baseline visit 5.Informed consent 6.Media clarity, pupillary dilatation and patient cooperation sufficient for fundus photography.

Exclusion Criteria

• other ocular diseases like AMD eyes, diabetic retinopathy, disc pallor 2.
• recent CVA, MI or major ischemic event 3 months preceding baseline visit 3.
• known sensitivity to any anti-VEGF drugs and sodium fluorescein 4.
• previous macular or pan retinal photocoagulation 5.previous anti-VEGF treatment 6.no consent 7.patient not willing for follow up.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BCVA ( snellens visual acuity and ETDRS)	1 month, 3 months, 6 months

Secondary Outcome Measures

Name	Time	Method
OCT	number of ranibizumab injections

Trial Locations

Locations (1)

RPC, AIIMS; 🇮🇳 South, DELHI, India

RPC, AIIMS

🇮🇳South, DELHI, India

Dr Siddhi Goel

Principal investigator

9810032869

siddhigoel91@gmail.com