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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00599222
Enrollment
100
Registered
2008-01-23
Start date
2008-02-29
Completion date
2010-02-28
Last updated
2011-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neovascular Age-related Macular Degeneration

Keywords

AMD, macular degeneration, anti-VEGF, laser 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.

Interventions

BIOLOGICALranibizumab

0.5 mg intravitreal injection

PROCEDURETTT

Transpupillary thermotherapy (TTT)

PROCEDURESham TTT

Sham Transpupillary thermotherapy (TTT)

Sponsors

Anders Kvanta
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The proportion of patients that will need 5 injections (loading phase excluded) or less with ranibizumab1 year

Secondary

MeasureTime frame
Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart1 year
Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart1 year

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 27, 2026