A study to evaluate the effect of Lucentis® (Ranibizumab) on Vision Related Function using the VFQ-25 questionnaire in patients with wet age-related macular degeneration (AMD)

Phase 4

• Conditions: age-related macular degeneration (AMD)

• Registration Number: CTRI/2010/091/000379
• Lead Sponsor: Novartis health care private limited

Brief Summary

Multi-centre, open-label, non-comparative, prospective, observational, post marketing surveillance (PMS) study in a real practice setting, for evaluation of mean change in VFQ-25 subscale scores over 12 months, in patients with wet age-related macular degeneration (AMD) treated with Lucentis.The study population will consist of patients with neovascular (wet) age related macular degenaration (AMD). The primary outcome of this study is the Mean change from baseline in VFQ-25 subscale scores\* at 3, 6 & 12 months

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 500

Inclusion Criteria

1.Diagnosed with choroidal neovascularization (CNV) secondary to (wet) AMD2.Willing to provide informed consent (as per the local practices)Patients may have received Lucentis monotherapy or combination therapy [with Visudyne® (verteporfin)].

Exclusion Criteria

1.Hypersensitivity to the active substance or to any of the excipients.2.Patients with active or suspected ocular or periocular infections.3.Patients with active intraocular inflammation.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean change from baseline in VFQ-25 subscale scores* at 3, 6 & 12 months *VFQ 25 Subscales: Near Vision Activities, Distance Vision Activities, Colour Vision, Vision Specific Dependency, Vision Specific Social Function, Vision Specific Mental Health	3, 6 and 12 months

Secondary Outcome Measures

Name	Time	Method
?Mean change from baseline in VFQ-25 subscale scores** at 3 , 6 & 12 months ?Mean change from baseline in VFQ-25 composite score at 3 , 6 & 12 months ?Proportion of patients who gain &#8805; 0, 1, 2, 3 lines of visual acuity from baseline at months 3 ,6 & 12 ?Proportion of patients who lose < 3 lines of visual acuity from baseline at months 3 , 6 & 12 ?Mean change from baseline in VFQ-25 subscale scores* at 12 months ?Mean change from baseline in VFQ-25 subscale scores** at 12 months ?Mean change from baseline in VFQ-25 composite score at 12 months	3, 6 and 12 months

Trial Locations

Locations (1)

Dr. Muljiani Clinic; 🇮🇳 Mumbai, MAHARASHTRA, India

Dr. Muljiani Clinic

🇮🇳Mumbai, MAHARASHTRA, India

Dr. R. H. Muljiani

Principal investigator

022-66573290

rahimmuljiani@hotmail.com