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

Not Applicable

Withdrawn

• Conditions: Macular Edema
• Interventions: Drug: Ranibizumab; Drug: Ranibizumab monotherapy

• Registration Number: NCT00726973
• Lead Sponsor: Lahey Clinic

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 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.

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 by an intravitreal injection of Lucentis. Subjects in arm 1 will receive 2 additional injections of Ranibizumab (Lucentis) over the next 2 months. Starting at month 3, they will receive combination reduced fluence PDT and intravitreal Ranibizumab (Lucentis) if they develop recurrence of the subretinal fluid, cystoid macular edema, increased pigment epithelial detachment (PED), or increased retinal thickness \> 100 microns compared to the best prior thickness measure on OCT. Patients will be eligible for repeat combination reduced fluence PDT + intravitreal Ranibizumab (Lucentis) every 3 months thereafter. Group 1 patients are eligible for treatment with combination reduced fluence PDT and Ranibizumab (Lucentis) at any point at the 3 month time point or thereafter. After month 3, if patients were not eligible for combined therapy (\<3 months since the last combination therapy) and have \>2 lines of vision loss or \> 100 microns of increased retinal thickness on OCT compared to most recent measure at their monthly visit, they would be eligible for an injection of Ranibizumab (Lucentis) as monotherapy. Thereafter, subjects will have combination therapy if retreatment criteria were met and it has been \>3 months since the last PDT treatment.

Study arm 2 will receive 3 monthly intravitreal injections of Ranibizumab (Lucentis). Following month 2, they will be eligible for re-treatment with Ranibizumab (Lucentis) if retreatment criteria are met (same criteria as study arm 1). At intervals of no less than 3 months from the previous sham PDT, they will receive sham PDT if retreatment criteria are met.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2008-07-30
• Study First Submitted QC: 2008-07-31
• Study First Posted: 2008-08-01
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-09
• Last Update Posted: 2012-05-10
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Ranibizumab	Reduced fluence (3300mW/cm2-50% standard fluence) PDT + ranibizumab
2	Ranibizumab monotherapy	Ranibizumab monotherapy

Primary Outcome Measures

Name	Time	Method
Primary efficacy will be proportion of subjects with best corrected visual acuity improvement of 15 or more letters from baseline and wil visual acuity stabilization, less than 15 letter loss from baseline at 13 months	at conclusion of subject enrollment

Secondary Outcome Measures

Name	Time	Method
Mean change in ETDRS from baseline, number of Ranibizumab treatments w/reduced fluence PDT, proportion of patients with 6 lines of vision loss	at conclusion of subject enrollment