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

Anders Kvanta

Status and phase: Completed; Phase 3

Conditions: Neovascular Age-related Macular Degeneration

Treatments: Procedure: Sham TTT; Biological: ranibizumab; Procedure: TTT

Study type: Interventional

Funder types: Other

Identifiers

NCT00599222

LUTA001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

TTT

Active Comparator group

Description:

TTT is given every three months

Treatment:

Biological: ranibizumab

Procedure: TTT

Sham TTT

Sham Comparator group

Description:

Sham TTT is given every three months

Treatment:

Procedure: Sham TTT

Biological: ranibizumab