Study of Treatment Effects of Combination Therapy of Lucentis Plus Reduced Fluence PDT With Visudyne in Patients With Exudative AMD

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: reduced fluence photodynamic therapy with Visudyne
* Drug: Lucentis


Participation Criteria
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Eligibility Criteria
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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 Previous treatment for CNV with anti-VEGF agents, intraocular steroids and/or Photodynamic therapy with Visudyne® in the study eye Geographic atrophy or fibrosis in the study eye Intraocular surgery within 6 weeks of enrollment Subretinal hemorrhage > 50% of the total lesion Patients with intraocular pressure greater than 30 mm/Hg on 2 pressure-lowering medications Patients with severe disciform scarring. Inability to make study visits Advanced glaucoma Allergies to porfins or a known hypersensitivity to any component of Visudyne® Patients with porphyria Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lucentis plus Reduced Fluence PDT same day<br> | Drug: reduced fluence photodynamic therapy with Visudyne<br>* reduced fluence photodynamic therapy with visudyne<br>Drug: Lucentis<br>* Lucentis intravitreal injection<br>|
| Active Comparator: Lucentis plus reduced fluence PDT 1-2 weeks later<br> | Drug: reduced fluence photodynamic therapy with Visudyne<br>* reduced fluence photodynamic therapy with visudyne<br>Drug: Lucentis<br>* Lucentis intravitreal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety of the combination therapy |  | 12 months and 24 months | 
| To assess efficacy of the two timing regimens |  | 12 months and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the number of Lucentis injections and the number of PDT treatments required during the study |  | 12 months and 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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macular degeneration