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.

Not Applicable

Completed

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

• Registration Number: CTRI/2021/11/037815
• Lead Sponsor: ovartis Healthcare Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-02-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 63

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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. <br/ ><br>2.To evaluate the effectiveness of brolucizumab on fluid (IRF, SRF, PED) from baseline to Months 1 and 2. <br/ ><br>3.To evaluate the effectiveness of brolucizumab on central retinal thickness (CRT) from baseline to Months 1, 2, and 3. <br/ ><br>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. <br/ ><br>5. To describe the ocular and non-ocular safety of brolucizumab.Timepoint: 1. Baseline, Month 01,Month 02 and Month 03 <br/ ><br> <br/ ><br>2. Baseline, Month 01,Month 02 and Month 03 <br/ ><br> <br/ ><br>3. Baseline, Month 01,Month 02 and Month 03 <br/ ><br> <br/ ><br>4. Baseline, Month 01,Month 02 and Month 03 <br/ ><br> <br/ ><br>5. Baseline, Month 01,Month 02 and Month 03