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

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

December 31, 2006

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions
Macular Edema
Interventions
DRUG

Ranibizumab

Ranibizumab, and reduced fluence PDT or sham PDT and Ranibizumab. For 2 months injected intravitreal Ranibizumab will be given. At month 3 subjects will receive combination reduced fluence PDT and intravitreal Ranibizumab. If they develop recurrence of subretinal fluid, cystoid macular edema, increased pigment epithelial detachment (PED), or increased retinal thickness \>100 microns compared to best thickness measure of OCT, subjects will be eligible for repeat combination reduced fluence PDT + intravitreal Ranibizumab every 3 months thereafter.

DRUG

Ranibizumab monotherapy

3 monthly intravitreal injections of Ranibizumab monotherapy. After month 2 they are eligible for retreatment with Ranibizumab if retreatment criteria are met (same as 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.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Lahey Clinic

OTHER

NCT00726973 - Pilot Study Reduced Fluence PDT /Visudyne With Ranibizumab vs Ranibizumab Monotherapy for Exudative Age-related Macular Degeneration (AMD) | Biotech Hunter | Biotech Hunter