The Ranibizumab Plus Transpupillary Thermotherapy for Neovascular Age-Related Macular Degeneration (AMD) Study

Study Overview
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Brief Summary
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Neovascular age-related macular degeneration (AMD) is the leading cause of severe vision loss in the Western world. Intravitreal ranibizumab has recently become the treatment of choice for neovascular (AMD). Limitations to ranibizumab however include the high cost for the drug and the need for frequent intravitreal re-injections. The investigators' hypothesis is that when ranibizumab is combined with transpupillary thermotherapy (TTT) the number of necessary retreatments with Lucentis will be significantly reduced as compared to ranibizumab alone.

Detailed Description
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Neovascular age-related macular degeneration (AMD) is caused by an ingrowth of pathological vessels under the macula. Experimental studies have demonstrated that vascular endothelial growth factor (VEGF) is centrally involved in this process. For this reason, anti-VEGF drugs, in particular ranibizumab, as become the treatment of choice for neovascular AMD. Ranibizumab use is limited by its high cost. Also, ranibizumab requires repeated (sometimes up to monthly) intravitreal injections for many years. Strategies to reduce the burden of this treatment on the patient as well as on the health care system will be critical. Combination therapy is an attractive such possibility. Transpupillary thermotherapy (TTT) is a technique by which vascular occlusion can be induced by delivering radiation at near infrared intensity to the target tissue through the pupil. Several reports have indicated that TTT may be used to slow disease progression in patients with neovascular AMD. In this study we examine whether combined ranibizumab and TTT will reduce the number of ranibizumab injections compared with ranibizumab alone (sham TTT). The study will go on for 2 years with an interim report after 1 year.

Official Title
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A Prospective, Randomized, Controlled Study on Intravitreal Ranibizumab (Lucentis) Combined With Transpupillary Thermotherapy (TTT) for Neovascular Age-related Macular Degeneration (AMD)

Conditions
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Neovascular Age-related Macular Degeneration

Intervention / Treatment
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* Biological: ranibizumab
* Procedure: TTT
* Procedure: Sham TTT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with subfoveal neovascular AMD with either classic/predominantly classic or occult lesions visual acuity => 20/200 Exclusion Criteria: subretinal fibrosis or atrophy under the fovea patients previously treated for neovascular AMD in the study eye

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TTT<br>TTT is given every three months | Biological: ranibizumab<br>* 0.5 mg intravitreal injection<br>* Other names: Lucentis;Procedure: TTT<br>* Transpupillary thermotherapy (TTT)<br>|
| Sham Comparator: Sham TTT<br>Sham TTT is given every three months | Biological: ranibizumab<br>* 0.5 mg intravitreal injection<br>* Other names: Lucentis;Procedure: Sham TTT<br>* Sham Transpupillary thermotherapy (TTT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients that will need 5 injections (loading phase excluded) or less with ranibizumab |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart |  | 1 year | 
| Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AMD, macular degeneration, anti-VEGF, laser treatment