Efficacy and Safety Study of Lucentis (Ranibizumab) and Visudyne (Verteporfin) Combination Therapy in Neovascular AMD

Conditions

• Neovascular Age Related Macular Degeneration

Eligibility Criteria

Sex

ALL

Age

50 Years - 95 Years

Healthy Volunteers

Not accepted

Interventions

• Ranibizumab; Verteporfin — DRUG
  Patients will be administered Lucentis™ 0.5 mg on Day 1, at Months 1 and 2, and then as needed at intervals of at least 30 days through Month 11 based on the retreatment criteria algorithm. These patients will also be administered Visudyne® only on Day 3.

Study Details

This study is designed to evaluate the effect of Visudyne® combination therapy (Visudyne® \[verteporfin for injection\] and Lucentis™) on visual acuity outcomes. Study results will be submitted for publication to provide data that may help physicians refine the clinical management of patients with CNV secondary to age-related macular degeneration (AMD).

Key Dates

Start date

Jan 31, 2008

Status verified

Oct 2009

Primary completion

Jun 30, 2009

Completion

Oct 31, 2009

Study Design

Enrollment

15 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: A
  A: This will be a single arm study. Patients will be administered Lucentis™ on Day 1,at Months 1 and 2, and then as needed at intervals of at least 30 days through Month 11 based on the retreatment criteria algorithm. These patients will also be administered Visudyne® only on Day 3.

Primary Outcome Measure

the mean change from baseline in BCVA letters with ETDRS at Month 3,6,12. -the number of retreatments, the treatment-free interval and the % of retreated patients at month 3, 6, 12. -the mean retinal thickness change from baseline at month 3, 6 and 12. [ Time Frame: 12 months ]