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A Clinical study observing results of treatment with Brolucizumab in patients with wet age-related macular degeneration (leading to vision loss) in the Indian population.

A retrospective study to evaluate the early real-world evidence of brolucizumab in patients with neovascular Age-related Macular Degeneration (nAMD) in India

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/11/037815
Enrollment
44
Registered
2021-11-03
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Novartis Healthcare Private Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Treatment -naive nAMD patients or patients previously treated with single or a combination of other intravitreal anti-VEGFs 2. Patients (male or female) more than or equal to 50 years of age at the index date 3. Patients with visual acuity (VA) and Optical coherence tomography (OCT) assessments at baseline and at least 1 month after initiating treatment with brolucizumab 4. Patients treated with intravitreal injection of brolucizumab (received first dose of anti-VEGF injection during the Index period 01 October 2020 to 31 March 2021

Exclusion criteria

Exclusion criteria: 1. Patients with dry AMD, geographic atrophy, and other retinal diseases in the study eye 2. Patients who were part of any other nAMD trial/study during the study period 3. Patients undergoing additional ocular treatment along with anti-VEGF agents

Design outcomes

Primary

MeasureTime frame
1. To evaluate the effectiveness of brolucizumab on fluid (intra-retinal fluid [IRF], sub-retinal fluid [SRF], as well as pigment epithelial detachment [PED]) from baseline to Month 3Timepoint: 1. Baseline, Month 01,Month 02 and Month 03—

Secondary

MeasureTime frame
1.To evaluate the effectiveness of brolucizumab in management of nAMD in terms of change in best-corrected visual acuity (BCVA) from baseline to Month 3. 2.To evaluate the effectiveness of brolucizumab on fluid (IRF, SRF, PED) from baseline to Months 1 and 2. 3.To evaluate the effectiveness of brolucizumab on central retinal thickness (CRT) from baseline to Months 1, 2, and 3. 4. To characterize the number of anti-VEGF injections, non-injection visits, and total number of visits during the first 3 months of treatment with brolucizumab during this study. 5. To describe the ocular and non-ocular safety of brolucizumab.Timepoint: 1. Baseline, Month 01,Month 02 and Month 03 2. Baseline, Month 01,Month 02 and Month 03 3. Baseline, Month 01,Month 02 and Month 03 4. Baseline, Month 01,Month 02 and Month 03 5. Baseline, Month 01,Month 02 and Month 03—

Countries

India

Contacts

Public ContactDr Maulik Bhavsar

Novartis Healthcare Pvt. Ltd.

maulik.bhavsar@novartis.com022-50243000

Outcome results

None listed

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