Status:
WITHDRAWN
Pilot Study Reduced Fluence PDT /Visudyne With Ranibizumab vs Ranibizumab Monotherapy for Exudative Age-related Macular Degeneration (AMD)
Lead Sponsor:
Lahey Clinic
Conditions:
Macular Edema
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
The purposes of this study is to determine if combination reduced fluence photodynamic therapy and Ranibizumab has: Similar efficacy to Ranibizumab (Lucentis) alone. The ability to reduce the number ...
Detailed Description
This will be a 13 month prospective, blinded, randomized sham controled parallel safety study. There will be 2 treatment arms. Arm 1 will receive reduced fluence PDT at baseline followed immediately ...
Eligibility Criteria
Inclusion
- Male / Female \> 50 years of age
- FA diagnosis of CNV lesions as described above
- Have a best corrected visual acuity letter score in the study eye between 72-24 letters (approximately 20/40 to 20/320) using ETDRS chart measured at 4 meters
- Central retinal (including lesion) thickness greater than or equal to 250 microns as measured by OCT
- Subretinal hemorrhage making up less than 50% of total lesion size and sparing the fovea
- Sufficiently clear ocular media including the lens to allow photography of the retina
- Written informed consent has been obtained.
Exclusion
- Dense subfoveal hemorrhage (\>50% of the lesion)
- Tear or rip of the retina pigment epithelium, idiopathic parafoveal telangiectasis or serous pigment epithelial detachment without CNV
- Geographic atrophy involving the foveal center
- Subretinal fibrotic scar in the study eye greater than 25% of the lesion
- Presence of any condition in study eye other than AMD known to be associated with CNV
- History diabetic retinopathy or diabetic macular edema
- Previous pars plana vitrectomy
- Previous photodynamic therapy in the study eye
- Previous photodynamic therapy in the fellow eye with resultant choroidal hypoperfusion
- Previous intravitreal anti-VEGF or steroid injection in the study eye
- Previous thermal subfoveal laser treatment in study eye
- Anticipated need for ocular surgery in the study eye during the 13 month study period
- Known allergy or sensitivity to the study medication(s) its components, diagnostic agents used during the study (Fluorescein, dilation drops) or other agents required for the study procedures (ie: povidone iodine)
- Porphyria or other porphyrin sensitivity
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00726973
Start Date
December 1 2006
End Date
July 1 2012
Last Update
May 10 2012
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.