Status:
COMPLETED
Combination Lucentis and Ocular Photodynamic Therapy With Visudyne, With Evaluation-based Retreatment
Lead Sponsor:
Illinois Retina Associates
Collaborating Sponsors:
Novartis Pharmaceuticals
Conditions:
Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief 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 t...
Eligibility Criteria
Inclusion
- Presence of subfoveal CNV due to AMD, less than 9 disc areas in extent
- Vision 20/40 to 20/800 Snellen equivalent
- Age \> 50 years
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
Exclusion
- Intraocular surgery or injection within 30 days prior to enrollment in the study eye
- Intravitreal triamcinolone within the past 6 months in the study eye
- History of prior PDT treatment in the study eye
- History of argon laser treatment of subfoveal CNV in the study eye
- Other vision-limiting disease (e.g. advanced glaucoma, prior vascular occlusion, dense amblyopia) in the study eye
- Clinically significant intraocular inflammation in the study eye
- No light perception in the fellow eye
- Anterior segment opacity preventing adequate visualization of fundus for FA or OCT
- Are currently participating in another clinical trial
- Women of childbearing potential not using adequate contraception, as well as women who are breastfeeding
- Known sensitivity to study drug(s) or class of study drug(s)
- Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- Use of any other investigational agent in the last 30 days
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00680498
Start Date
February 1 2007
End Date
October 1 2009
Last Update
March 28 2012
Active Locations (1)
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1
Illinois Retina Associates
Oak Park, Illinois, United States, 60304