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)

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000379

Enrollment

500

Registered

2010-04-29

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

None listed

Interventions

Intervention1: RANIBIZUMAB: 0.5 mg(0.05 ml) intravitreal injection administered as 3 monthly loading doses and then on a Prn basis (as per requirement ) Control Intervention1: NOT APPLICABLE:

Eligibility

Inclusion criteria

Inclusion criteria: 1.Diagnosed with choroidal neovascularization (CNV) secondary to (wet) AMD 2.Willing to provide informed consent (as per the local practices) Patients may have received Lucentis monotherapy or combination therapy [with Visudyne® (verteporfin)]

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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 HealthTimepoint: 3, 6 and 12 months	—

Secondary

Measure	Time frame
?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 Timepoint: 3, 6 and 12 months	—

Measure

Time frame

?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 Timepoint: 3, 6 and 12 months

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Countries

India

Contacts

Public ContactDr. Prashant Dongre

prashant,dongre@novartis.com022-24958589

Outcome results