Clinical trial NCT00599222: The Ranibizumab Plus Transpupillary Thermotherapy for Neovascular Age-Related Macular Degeneration (AMD) Study
Official title: A Prospective, Randomized, Controlled Study on Intravitreal Ranibizumab (Lucentis) Combined With Transpupillary Thermotherapy (TTT) for Neovascular Age-related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neovascular Age-related Macular Degeneration
Keywords: AMD
macular degeneration
anti-VEGF
laser treatment
Lead sponsor: St. Erik Eye Hospital
Sponsor class: OTHER
First posted: 2008-01-23
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The proportion of patients that will need 5 injections (loading phase excluded) or less with ranibizumab
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart
timeFrame: 1 year
measure: Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart
timeFrame: 1 year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: St Eriks Eye Hospital
Study officials:
affiliation: St Eriks Eye Hospital
name: Anders Kvanta
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soderberg AC, Algvere PV, Hengstler JC, Soderberg P, Seregard S, Kvanta A. Combination therapy with low-dose transpupillary thermotherapy and intravitreal ranibizumab for neovascular age-related macular degeneration: a 24-month prospective randomised clinical study. Br J Ophthalmol. 2012 May;96(5):714-8. doi: 10.1136/bjophthalmol-2011-300721. Epub 2012 Jan 12.