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A Randomised Control Study To Compare The Efficacy Of Intravitreal Faricimab6.0 mg Versus Aflibercept 2.0 mg In Management of Treatment Naive Diabetic Macular Edema In Indian Population

A Randomised Control Study To Compare The Efficacy Of Intravitreal Faricimab6.0 mg Versus Aflibercept 2.0 mg In Management of Treatment Naive Diabetic Macular Edema In Indian Population - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/09/073550
Enrollment
72
Registered
2024-09-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Health Condition 1: E113- Type 2 diabetes mellitus with ophthalmic complications

Interventions

Intervention1: FARICIMAB: INTRAVITREAL FARICIMAB 6.0 MG TO BE ADMINISTERED . Patients will be examined at 0, 4 & 8 weeks and all patients will receive 3 four-weekly loading dose. Following this all pa

Sponsors

Army Hospital Research And Referral
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 18 years and above Piagnosed with Diabetic Macular Edema Patients willing to participate in study.

Exclusion criteria

Exclusion criteria: Patients with other retinal diseases decreased visual acuity due to causes other than macular edema macular edema due to causes other than diabetes mellitus any form of central cataract in phakic patients posterior capsular opacity/iol subluxation in pseudophakic patients history of any uveitis, pregnant and lactating females.

Design outcomes

Secondary

MeasureTime frame
to compare efficacy of faricimab vs aflibercept in improving BCVA, reduction in Central macular thickness and inter injection interval .Timepoint: follow up at zero week, then 4 week then every 4 weekly till 48 weeks.

Primary

MeasureTime frame
To compare the efficacy of intravitreal faricimab 6.0mg vs aflibercept 2.0 mg in diabetic macular edema in Indian populationTimepoint: follow up at zero week, then 4 week then every 4 weekly till 48 weeks.

Countries

India

Contacts

Public ContactPRADEEP KUMAR

Army Hospital Research And Referral New Delhi

mridasharma@gmail.com07292047066

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026