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

Sponsor
Lahey Clinic
Study ID
NCT00726973
Status
Withdrawn

Conditions

  • Macular Edema

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    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.
  • Ranibizumab monotherapy — DRUG
    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.

Study Details

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.

Key Dates

First listed
Aug 1, 2008
Start date
Dec 31, 2006
Status verified
May 2012
Primary completion
Jul 31, 2012
Completion
Jul 31, 2012

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Reduced fluence (3300mW/cm2-50% standard fluence) PDT + ranibizumab
  • Active Comparator: 2
    Ranibizumab monotherapy

Primary Outcome Measure

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 [ Time Frame: at conclusion of subject enrollment ]

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