An Open-Label, Single-Site, Comparative, Pilot Study of the Treatment Effects of Combination Therapy of Lucentis (Ranibizumab) Plus Reduced Fluence Photodynamic Therapy With Visudyne in Patients With Exudative Age-Related Macular Degeneration (AMD)
Overview
- Phase
- Not Applicable
- Sponsor
- Barnes Retina Institute
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- To assess the safety of the combination therapy
Overview
Brief Summary
The purpose of this study is to determine the benefits, if any, of combination therapy with Lucentis plus reduced fluence photodynamic therapy with Visudyne.
Detailed Description
The study will have two treatment groups. Each group will receive intravitreal injections (injection of medication in the jelly-like part of the back of the eye). One group (Group1) of approximately 15 patients will receive 0.5 mg of Lucentis™ followed by reduced fluence Photodynamic Therapy (PDT) with Visudyne ® 1-2 weeks later. The other group (Group 2) of approximately 15 patients will receive 0.5 mg of Lucentis™ followed by Photodynamic Therapy with Visudyne on the same day. patients will be assigned at random to receive one of the two treatments arms in the study. The dose received at the first injection will be the same dose received throughout the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ability to give informed consent
- •Treatment- naïve patients with active, subfoveal, exudative AMD
- •Patients with visual acuity of 20/40-20/320 in the study eye
- •Subfoveal choroidal neovascularization (CNV) must be at least 50% of the total lesion size Total area of lesion components other that CNV must be less than 50% of the total lesion size
- •The lesion must be \< 5400microns in greatest linear dimension (GLD)
- •Lesion size \< 10 DA
- •Occult with no classic CNV lesions must have presumed recent disease progression:
- •Blood associated with the lesion at baseline
- •Loss of visual acuity in the previous 3 months: a: \> 5 letter loss (ETDRS equivalent) or b: 2 or more lines using a snellen or equivalent chart
- •\> 10% increase in GLD as assessed by fluorescein angiography in the previous 3 months
Exclusion Criteria
- Not provided
Arms & Interventions
Lucentis plus Reduced Fluence PDT same day
Intervention: reduced fluence photodynamic therapy with Visudyne (Drug)
Lucentis plus Reduced Fluence PDT same day
Intervention: Lucentis (Drug)
Lucentis plus reduced fluence PDT 1-2 weeks later
Intervention: reduced fluence photodynamic therapy with Visudyne (Drug)
Lucentis plus reduced fluence PDT 1-2 weeks later
Intervention: Lucentis (Drug)
Outcomes
Primary Outcomes
To assess the safety of the combination therapy
Time Frame: 12 months and 24 months
To assess efficacy of the two timing regimens
Time Frame: 12 months and 24 months
Secondary Outcomes
- To evaluate the number of Lucentis injections and the number of PDT treatments required during the study(12 months and 24 months)