Combination Lucentis and Ocular Photodynamic Therapy With Visudyne, With Evaluation-based Retreatment

Part of paid clinical trials in Oak Park, Illinois.

Sponsor: Illinois Retina Associates
Study ID: NCT00680498
Phase: PHASE4
Status: Completed

Conditions

Age-Related Macular Degeneration

Eligibility Criteria

Sex: ALL
Age: 50 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Ranibizumab — DRUG
Ranibizumab 0.5 mg
Ranibizumab plus Photodynamic therapy — DRUG
Ranibizumab 0.5mg, combined with photodynamic therapy with Verteporfin (dosage per label)

Study Details

This is a one-year, randomized, single-center open-label pilot study of the safety and efficacy of combination ranibizumab and PDT for AMD. Eligible subjects will be randomized to either combination treatment, or ranibizumab monotherapy (control group). The combination treatment group will receive ranibizumab, followed 1 week later by verteporfin PDT. Additional treatments will be based on evidence of active disease (subretinal fluid on OCT or leakage on FA): repeat ranibizumab injections will be allowed monthly, and repeat PDT will be allowed every 3 months. The control group will receive "standard-of-care" ranibizumab monotherapy according to the protocol currently followed by most retinal specialists. Ranibizumab injections will be given at baseline and months one and two. Additional injections will be given at each monthly visit at which there is evidence of active disease by visual acuity, OCT and FA criteria.