To compare the effect of two different intraocular injections in diabetic related retinal disease

Phase 4

Completed

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2023/09/058134
• Lead Sponsor: Dr Vipin Rana

Brief Summary

No inferiority of brlolucizumab to aflibercept to the change visual acuity from baseline upto week 24. Intravitreal anti-VEGF injections remain the gold standard for management of chorioretinal vascular disease including AMD, DME,RVO.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2023-09-27
• Study Start: 2023-10-17
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Male and female patients >18 years old with visual impairment due to DME.
• Patients with type 1 or type 2 diabetes mellitus and Hba1c of <10% at screening.
• Patient or legally acceptable representative willing to voluntarily provide signed informed consent for participation in the study.

Exclusion Criteria

• Patient with existing or suspected ocular or periocular infection in the study eye.
• Patient with uncontrolled glaucoma defined as intraocular pressure >25 mmhg despite treatment with antiglaucoma medication, or according to investigators judgement.
• Patient having scar, fibrosis and atrophy involving the center of the fovea in the study eye.
• Active proliferative diabetic retinopathy in the study eye as per investigator.
• Previous treatment with any anti-vegf drugs or investigational drugs in the study eye.
• 6.Laser photocoagulation (focal/grid or panretinal) in the study eye during the 3 month period prior to baseline.
• Intraocular surgery including YAG laser in the study eye during the 3 month period prior to baseline.
• Pregnant or nursing women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Non-inferiority of brolucizumab to aflibercept with respect to change in visual acuity from baseline upto week24	1 year 6 month

Secondary Outcome Measures

Name	Time	Method
To characterize the number of anti-VEGF injections, non-injection visits,and total number of visits during the study, to evaluate the effectiveness of brolucizumab on fluid(IRF,SRF) from baseline to 4th week 8th week,12th week & 24 th week to evaluate the effectiveness of brolucizumab on central retinal thickness from baseline to week 24	1year 6 months

Trial Locations

Locations (1)

Command Hospital, Eastern Command; 🇮🇳 Kolkata, WEST BENGAL, India

Command Hospital, Eastern Command

🇮🇳Kolkata, WEST BENGAL, India

Satyaki Mondal

Principal investigator

7319342492

satyaki.mondal10@gmail.com