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

NCT00680498 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-03-28

No results posted yet for this study

Summary

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.

Conditions

  • Age-Related Macular Degeneration

Interventions

DRUG

Ranibizumab

Ranibizumab 0.5 mg

DRUG

Ranibizumab plus Photodynamic therapy

Ranibizumab 0.5mg, combined with photodynamic therapy with Verteporfin (dosage per label)

Sponsors & Collaborators

Principal Investigators

  • Pauline T Merrill, MD · Illinois Retina Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-02-28
Primary Completion
2009-07-31
Completion
2009-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00680498 on ClinicalTrials.gov