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

A PROSPECTIVE COMPARATIVE LONGITUDINAL STUDY OF EFFICACY OF BROLUCIZUMAB 6.0 MG VERSUS AFLIBERCEPT 2.0 MG IN NEOVASCULAR AGE RELATED MACULAR DEGENERATION IN INDIAN POPULATION

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/06/034415
Enrollment
74
Registered
2021-06-28
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: H353- Degeneration of macula and posterior pole

Interventions

Intervention1: BROLUCIZUMAB 6.0 MG: ADMINISTRED INTRAVITREALLY BROLUCIZUMAB 6.0 MG IN AFFECTED EYE.TREATMENT CONSISTS OF THREE LOADING DOSES AT MONTHLY INTERVAL(0,4 AND 8 WEEKS) FOLLOWING WHICH ALL PA

Sponsors

Army Hospital Research and ReferralDelhi
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
To establish non-inferiority of Brolucizumab as compared to Aflibercept in terms of best corrected visual acuity from baseline to 36 weeksTimepoint: At the end of 36 weeks—

Secondary

MeasureTime frame
To determine the number of patients maintaining q12weeks dosing interval of Brolucizumab Timepoint: At the end of 36 weeks—

Countries

India

Contacts

Public ContactDr Srishti Khullar

Army Hospital Research And Referral

sanjusonu_2000@yahoo.com9811551327

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 11, 2026