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

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ClinicalTrials.gov Identifier: NCT00599222
Recruitment Status : Completed
First Posted : January 23, 2008
Last Update Posted : November 22, 2011
Sponsor:
Information provided by (Responsible Party):
Anders Kvanta, St. Erik Eye Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Biological: ranibizumab Procedure: TTT Procedure: Sham TTT Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Study on Intravitreal Ranibizumab (Lucentis) Combined With Transpupillary Thermotherapy (TTT) for Neovascular Age-related Macular Degeneration (AMD)
Study Start Date : February 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: TTT
TTT is given every three months
 Biological: ranibizumab
0.5 mg intravitreal injection
Other Name: Lucentis

Procedure: TTT
Transpupillary thermotherapy (TTT)
Sham Comparator: Sham TTT
Sham TTT is given every three months
 Biological: ranibizumab
0.5 mg intravitreal injection
Other Name: Lucentis

Procedure: Sham TTT
Sham Transpupillary thermotherapy (TTT)


Outcome Measures
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Primary Outcome Measures :
  1. The proportion of patients that will need 5 injections (loading phase excluded) or less with ranibizumab [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599222


Locations
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Sweden
St Eriks Eye Hospital
Stockholm, Sweden, 11282
Sponsors and Collaborators
Anders Kvanta
Investigators
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Principal Investigator: Anders Kvanta St Eriks Eye Hospital
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Anders Kvanta, Professor, St. Erik Eye Hospital
ClinicalTrials.gov Identifier: NCT00599222    
Other Study ID Numbers: LUTA001
First Posted: January 23, 2008    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011
Keywords provided by Anders Kvanta, St. Erik Eye Hospital:
AMD
macular degeneration
anti-VEGF
laser treatment
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
 Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents