Reduced Fluence Photodynamic Therapy (PDT) With Visudyne in Combination With Lucentis for Age-Related Macular Degeneration

Study Overview
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Brief Summary
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In this pilot study the researchers will evaluate the safety and efficacy of 50% reduced fluence PDT combination therapy with ranibizumab. The researchers hope to gain information regarding the use of reduced fluence PDT combination therapy. The information gained from this pilot study may prompt further definitive studies comparing the safety and efficacy of both standard fluence PDT combination therapy, reduced fluence PDT combination therapy, and ranibizumab monotherapy. The study will compare the use of combination therapy with ranibizumab and verteporfin PDT to ranibizumab alone in patients with exudative age-related macular degeneration (AMD). All patients will receive three consecutive monthly treatments with ranibizumab. Patients will be randomized 1:1:1 to 3 groups. Patients randomized to group 1 will receive only ranibizumab. Patients randomized to group 2 will also receive one treatment with reduced fluence (50% fluence) verteporfin PDT at day 0. Patients randomized to group 3 will also receive one treatment with standard fluence verteporfin PDT. All patients will also be evaluated for possible retreatment with ranibizumab and verteporfin PDT according to established criteria. Thirty patients will be recruited from one U.S. sites. Randomization will occur at the time of entry into the study. Follow-up will continue until month 12 (from day 0) in all subjects.

Official Title
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A Prospective Pilot Study of Reduced Fluence Photodynamic Therapy With Visudyne® (Verteporfin) in Combination With Lucentis™ (Ranibizumab) for the Treatment of Age-Related Macular Degeneration

Conditions
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Age-Related Maculopathy, Choroidal Neovascularization

Intervention / Treatment
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* Drug: Ranibizumab
* Drug: Verteporfin
* Drug: Verteporfin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female Patients > 50 years of age. Patients with primary subfoveal CNV secondary to AMD documented on IVFA and/or OCT. Patient with BCVA of 20/40 to 20/320 in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. See definition of ETDRS charts. If both eyes are eligible, only one eye will be evaluated in the study. The eye with lesser visual acuity will be selected as the study eye. Patients must be able and willing to provide written informed consent. Exclusion Criteria: Patients receiving prior treatment in the study eye with verteporfin, any focal laser photocoagulation, vitrectomy, or intravitreous injection of antiangiogenic medications, including triamcinolone, pegaptanib, bevacizumab, or ranibizumab. Neovascular membrane from any other retinal disease such as myopic degeneration, histoplasmosis, retinal angiomatous proliferation, or other ocular inflammatory disease. Choroidal neovascular membrane greater than 9 disc diameters in size. Previous posterior vitrectomy in the study eye. Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the study period. Pregnant women or premenopausal women not using adequate contraception. History of allergy to fluorescein, Visudyne, Lucentis. Inability to comply with study or follow up procedures.

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 |
| --- | --- |
| Experimental: 1<br>Standard Fluence Photodynamic Therapy combined with ranibizumab | Drug: Ranibizumab<br>* intravitreal administered ranibizumab 0.5 mg in 0.05 mL<br>* Other names: Lucentis;Drug: Verteporfin<br>* Verteporfin with standard fluence photodynamic therapy (50 J/cm2)<br>* Other names: Visudyne;|
| Experimental: 2<br>Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab | Drug: Ranibizumab<br>* intravitreal administered ranibizumab 0.5 mg in 0.05 mL<br>* Other names: Lucentis;Drug: Verteporfin<br>* Verteporfin with 50% fluence photodynamic therapy (25 J/cm2)<br>* Other names: Visudyne;|
| Active Comparator: 3<br>Ranibizumab monotherapy | Drug: Ranibizumab<br>* intravitreal administered ranibizumab 0.5 mg in 0.05 mL<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in BCVA of ETDRS Letters From Baseline at 12 Months | Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss. | 12 months | 
| Mean Letters Gained of Best Corrected Visual Acuity Using ETDRS Protocol | Visual acuity is often measured using a chart called the ETDRS chart (Early Treatment Diabetic Retinopathy Study). A letter score is calculated based on the number of letters that can be correctly identified from specified distances. Higher letter scores correspond to better visual acuity. Lower letter scores mean poorer visual acuity. In this study the baseline visual acuity in letters is subtracted from the visual acuity in letters measured at the 12 month visit providing a letter score of vision gain or vision loss. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to First Retreatment After Loading Doses |  | 12 months | 
| Average Number of PDT Retreatments Over 12 Months |  | 12 months | 
| Central Macular Thickness Reduction on OCT |  | 12 months | 
| Average Number of Ranibizumab Retreatments Over 12 Months |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ranibizumab, Lucentis, Verteporfin, Visudyne, Photodynamic therapy