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

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00599222
• Other study ID #: LUTA001
• Status: Completed
• Phase: Phase 3
• First received: January 10, 2008
• Last updated: November 21, 2011
• Start date: February 2008
• Est. completion date: February 2010

Study information

• Verified date: November 2011
• Source: St. Erik Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Biological:
• ranibizumab
0.5 mg intravitreal injection

Procedure:
• TTT
Transpupillary thermotherapy (TTT)
• Sham TTT
Sham Transpupillary thermotherapy (TTT)

Locations

Country	Name	City	State
Sweden	St Eriks Eye Hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Anders Kvanta

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients that will need 5 injections (loading phase excluded) or less with ranibizumab		1 year	No
Secondary	Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart		1 year	No
Secondary	Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart		1 year	No

External Links

•   Hospital homepage