Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV

Study Overview
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Brief Summary
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This pilot study is designed to evaluate the safety and efficacy of intravitreal ranibizumab used in combination with verteporfin photodynamic therapy (Visudyne®) compared to ranibizumab monotherapy for the treatment of subfoveal CNV secondary to AMD

Detailed Description
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Intravitreal ranibizumab has shown to increase average vision in patients with subfoveal CNV secondary to AMD. However, the treatment does not provide benefit to all patients and the treatment regimen requires monthly intravitreal injections. Ranibizumab is an anti-VEGF-A monoclonal antibody fragment. Verteporfin photodynamic therapy acts through occluding newly formed vessels. The combination of these therapies acting through different modes of action bears the potential to provide a more convenient and less frequent therapy while maintaining/improving the increase in vision improvement observed with ranibizumab monotherapy. The strategic goal is to evaluate whether intravitreal ranibizumab in combination with verteporfin photodynamic therapy is an effective, safe and convenient treatment for patients with subfoveal CNV secondary to AMD and explore potential advantages of such treatment compared to ranibizumab monotherapy

Official Title
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Randomized, Phase IIIb Study Comparing Safety, Tolerability and Efficacy Between Lucentis® Administered in Conjunction With PDT With Visudyne® and Lucentis® in Patients With Subfoveal CNV Secondary to Age-Related Macular Degeneration

Conditions
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Choroidal Neovascularization, Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: intravitreal ranibizumab
* Drug: intravitreal ranibizumab & photodynamic therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients over 50 years, subfoveal CNV of any type secondary to age-related macular degeneration (AMD), no macula-treatment for the last 30 days (e.g. with PDT, TA, Laser, Macugen®). the area of the CNV must occupy at least >50% of the lesion (total lesion size under 5400 microns in greatest linear dimension) Occult CNV: recent disease progression bleeding VA decreased the last three months >5 letters or 2 or more than two lines (Snellen) 10% increase of the lesion size the last three months Best corrected visual acuity score between 24-73 letters (20/40 to 20/320) (ETDRS 4 m) Exclusion Criteria: Prior treatment with mit Laser, PDT, Macugen, TA Prior treatment with radiatio, vitrectomy, transpupillary thermotherapy History of surgical intervention in the study eye within two months preceding day 1 concurrent use of systemic anti-VEGF agents previous treatment with or participation in a clinical trial involving anti-angiogenic drugs (Pegaptanib, ranibizumab, anecortave acetate of corticosteroids). Ocular disorders in the study eye that may confound interpretation of the study results, including retinal detachment or macular hole (Stage 3 or 4), active intraocular inflammation (grade trace or above) or persistent macular edema due to uveitis or other inflammatory diseases Retinal pigment epithelium tear, vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye History of idiopathic or autoimmune-associated uveitis in either eye, active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye Extracapsular extraction of cataract with phacoemulsification within two months preceding day 1, or a history of post-operative complications within the last 12 months preceding day 1 or a history of post-operative complications within the last 12 months preceding day 1 in the study eye (uveitis, cyclitis, iritis etc.) Glaucoma with IOP>25 mmHg despite therapy Aphakia or absence of the posterior capsule in the study eye Spherical equivalent >-8

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 95 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>intravitreal ranibizumab used in combination with verteporfin photodynamic therapy | Drug: intravitreal ranibizumab & photodynamic therapy<br>* intraocular injection photodynamic treatment (LASER) after intravenous injection<br>* Other names: Visudyne;|
| Active Comparator: B<br>intravitreal ranibizumab | Drug: intravitreal ranibizumab<br>* intraocular injection<br>* Other names: Lucentis;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First injection with PDT |  | monthly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monthly clinical evaluation of safety and necessity of re-intravitreal injection of ranibizumab after three initial injections |  | monthly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subfoveal choroidal neovascularization (CNV), age-related macular degeneration, ranibizumab monotherapy, combined verteporfin-therapy, Lucentis® (ranibizumab), Visudyne®, photodynamic therapy