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A multicentre,open-label,prospective,observational study to evaluate effectiveness and safety of repeated intravitreal injections of Lucentis® in patients with wet age-related macular degeneration over a 12-month observational period in a real-world setting

Utilizing Ranibizumab intravitreal Injection in a real world setting-A multicentre, open-label, prospective, observational study to evaluate effectiveness and safety of repeated intravitreal injections (IVI) of Lucentis® (ranibizumab) in patients with neovascular age-related macular degeneration (AMD) over a 12-month observational period in a real-world setting. - UNVEIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2013/08/003933
Enrollment
3000
Registered
2013-08-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Patients diagnosed with wet Age related Macular Degeneration

Interventions

Intervention1: Intravitreal Ranibizumab: 0.05 ml Intravitreally,once a month for three months and then as when required on PRN basis upto one year

Sponsors

Novartis India Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: � Presence of exudative age-related macular degeneration. � Patients for whome a therapy with Lucentis� is medically indicated. � Patients who consent to have their data collected. Patients will not need to consent to taking the drug, as their treatment is decided before entry into the study and is part of their medical care.

Exclusion criteria

Exclusion criteria: Any contra-indication according to local Summary of Product Characteristics or Prescribing Information (SmPC or PI) of Lucentis®.

Design outcomes

Primary

MeasureTime frame
Data of response of Ranibizumab un Indian patients with wet AMDTimepoint: At the end of three months

Secondary

MeasureTime frame
Number of injections required for vision stabilityTimepoint: 1 year

Countries

India

Contacts

Public ContactDr Ashray Naik

Novartis Healthcare Private Limited

ashray.naik@novartis.com24958579

Outcome results

None listed

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