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

Phase 3

Completed

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Biological: ranibizumab; Procedure: TTT; Procedure: Sham TTT

• Registration Number: NCT00599222
• Lead Sponsor: Anders Kvanta

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2008-01-10
• Study First Submitted QC: 2008-01-10
• Study First Posted: 2008-01-23
• Study Start: 2008-02
• Primary Completion: 2009-11
• Study Completion: 2010-02
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-21
• Last Update Posted: 2011-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham TTT	ranibizumab	Sham TTT is given every three months
TTT	ranibizumab	TTT is given every three months
TTT	TTT	TTT is given every three months
Sham TTT	Sham TTT	Sham TTT is given every three months

Primary Outcome Measures

Name	Time	Method
The proportion of patients that will need 5 injections (loading phase excluded) or less with ranibizumab	1 year

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

St Eriks Eye Hospital; 🇸🇪 Stockholm, Sweden