Pilot Study Reduced Fluence PDT /Visudyne With Ranibizumab vs Ranibizumab Monotherapy for Exudative Age-related Macular Degeneration (AMD)

• Status: Withdrawn
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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 of intravitreal injection of Ranibizumab or a 13 month period The ability to reduce the number of PDT treatments. The study will also collect information on the safety of combination therapy and single therapy.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lahey Clinic
• Treatments: Ranibizumab; Verteporfin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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