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Comparision between effective doses of Brolucizumab in Diabetic Macular Edema

TOPIC A COMPARATIVE STUDY OF INTRAVITREAL BROLUCIZUMAB 6.0 mg VERSUS 3.6 mg IN MANAGEMENT OF NAIVE CENTRE INVOLVING DIABETIC MACULAR EDEMA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/06/054105
Enrollment
62
Registered
2023-06-19
Start date
Unknown
Completion date
Unknown
Last updated
2023-06-26

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

Conditions

None listed

Interventions

Intervention1: BROLUCIZUMAB3.6mg: Each patient will be examined at 0 wk, 04 wk, 08 wk, 12 wk, 16 wk, 20 week and 24 week. Intravitreal injection of Brolucizumab will administered at 0 week, 08 week an

Sponsors

Army hospital research and referal delhi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Age more than 18 years with type 1 or type 2 diabetes. centre involving diabetic macular edema.

Exclusion criteria

Exclusion criteria: 1. Media opacity interfering with OCT acquistion 2. Prior treatement with laser photocoagulation 3.Prior Anti VEGF or Steroid administration 4. Decreased visual acuity due to causes other than diabetic macular edema 5.Macular edema due to unknown causes 6. Uncontrolled DM, HTN, Pregnancy, Lactation

Design outcomes

Primary

MeasureTime frame
The changes in central macular thickness, after intravitreal brolucizumab 6.0mg (group-1) vs 3.6mg (group-2) at 0wk to 24 wkTimepoint: The changes in central macular thickness, after intravitreal brolucizumab 6.0mg (group-1) vs 3.6mg (group-2) at 0wk to 24 wk—

Secondary

MeasureTime frame
To compare the changes in best corrected visual acuity in treatment of naive centre involving diabetic macular edema after intravitreal BROLUCIZUMAB 6.0mg vs 3.6mgTimepoint: To compare the changes in best corrected visual acuity in treatment of naive centre involving diabetic macular edema after intravitreal BROLUCIZUMAB 6.0mg vs 3.6mg—

Countries

India

Contacts

Public ContactDr Aman Saraf

INDIAN ARMY

sanjusonu_2000@yahoo.com9811551327

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 6, 2026