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Completed

NCT Number: NCT00599222

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

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.

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Key information

Conditions

Neovascular Age-related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St Eriks Eye Hospital

Stockholm, 11282, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Biological

0.5 mg intravitreal injection

Other names: Lucentis

TTT

Procedure

Transpupillary thermotherapy (TTT)

Sham TTT

Procedure

Sham Transpupillary thermotherapy (TTT)

Primary outcomes

  1. The proportion of patients that will need 5 injections (loading phase excluded) or less with ranibizumab

    Time frame: 1 year

Secondary outcomes

  1. Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart

    Time frame: 1 year

  2. Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Anders Kvanta

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2010
First posted
Jan 23, 2008
Registry last updated
Nov 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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