A CLINICAL TRIAL TO STUDY THE EFFICACY OF TWO DRUGS, BROLUCIZUMAB AND AFLIBERCEPT IN PATIENTS WITH NEOVASCULAR AGE RELATED MACULAR DEGENERATION IN INDIAN POPULATION

Completed

Conditions: Degeneration of macula and posterior pole,

Registration Number: CTRI/2021/06/034415

Lead Sponsor: Army Hospital Research and ReferralDelhi

Brief Summary: The duration of action of currently accepted first line treatment for neovascular age related macular degeneration is Ranibizumab and Aflibercept. The duration of action of Ranibizumab being 4 weeks and Aflibercept being 8 weeks. This creates a recurrent requirement of four weekly evaluation of patient leading to immense logistical and financial burden on patients. This study aims to compare Brolucizumab with Aflibercept in patients with neovascular age related macular degeneration in Indian population. Brolucizumab is a new molecule and is a longer acting drug. Brolucizumab offers a possibility of increasing the duration between hospital visits in patients of neovascular age related macular degeneration.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 74

Inclusion Criteria

a.Typical morphology of Age-Related Macular Degeneration b.Lesion affecting the central subfield (1 mm around centre) c.Active Choroidal Neovascularization d.CNV comprising more than 50% of total lesion area e.Intraretinal or Subretinal Fluid in central subfield f.BCVA between 20/32 to 20/400.

Exclusion Criteria

a.Any Fibrosis or geographical atrophy of central subfield b.Any intra or periocular infection or inflammation c.Patient has received any approved treatment for nAMD other than micronutrient supplementation d.Any concurrent intraocular disease like diabetic retinopathy e.History of drug sensitivity/ Allergic reactions to research interventions f.Stroke or MI in the 90 days preceding to baseline visit.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish non-inferiority of Brolucizumab as compared to Aflibercept in terms of best corrected visual acuity from baseline to 36 weeks	At the end of 36 weeks

Secondary Outcome Measures

Name	Time	Method
To determine the number of patients maintaining q12weeks dosing interval of Brolucizumab

Trial Locations

Locations (1): Army Hospital,Research and Referral
🇮🇳
West, DELHI, India
Army Hospital,Research and Referral
🇮🇳West, DELHI, India
Dr Srishti Khullar
Principal investigator
7478179087
srishtikhullar24@gmail.com