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Study to understand the characteristics, treatment patterns and outcomes in patients with Neovascular Age related macular degeneration

Non-Interventional Study Protocol (non-PASS) with secondary use of data To understand the characteristics, treatment patterns and outcomes in nAMD across various centers in India

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2020/12/029822
Enrollment
300
Registered
2020-12-15
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: H55-H57- Other disorders of eye and adnexa

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Novartis Healthcare Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed nAMD patients Patients (male or female) aged >=50 years of age at Index date Patients diagnosed with nAMD in at least one eye Patients with VA/OCT assessments at both baseline, Month 12 and Month 24 Patients treated with intravitreal injection of anti-VEGF (received at least one anti-VEGF injection during the post-index follow-up period and at least 2 visits with OCT in between Months 0-12). Patients with minimum follow-up period of 24 months. (received at least one anti-VEGF injection and at least 1 visit with OCT in between Months 13-24)

Exclusion criteria

Exclusion criteria: Patients with dry AMD, geographic atrophy and other retinal diseases Patients who were part of any other trial/ study Patients undergoing additional ocular treatment along with Anti VEGF agents will be excluded.

Design outcomes

Primary

MeasureTime frame
Association between anatomical outcomes (presence /absence) at Month 12 and changes in functional outcome from baseline to Month 12 will be investigated for the following endpoints: Anatomical outcomes at Month 12 IRF (presence / absence) SRF (presence / absence) Sub-RPE (presence/ absence) Functional outcomes at baseline and Month 12 VA change from baseline (in ETDRS letters) Timepoint: 12 months

Secondary

MeasureTime frame
To evaluate mean change in BCVA after the start of anti- VEGF therapy at Months 3, 6, 12, 18 and 24 as measured by ETDRS letters gained or lost.Timepoint: Months 3, 6, 12, 18 and 24

Countries

India

Contacts

Public ContactDr Maulik Bhavsar

Novartis Healthcare Pvt. Ltd.

maulik.bhavsar@novartis.com9723818482

Outcome results

None listed

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