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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anders Kvanta, St. Erik Eye Hospital
ClinicalTrials.gov Identifier:
NCT00599222
First received: January 10, 2008
Last updated: November 21, 2011
Last verified: November 2011
History of Changes
  Purpose

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 Intervention Phase
Neovascular Age-related Macular Degeneration
 Biological: ranibizumab
Procedure: TTT
Procedure: Sham TTT
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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)

Resource links provided by NLM:

Drug Information available for: Ranibizumab
U.S. FDA Resources

Further study details as provided by St. Erik Eye Hospital:

Primary Outcome Measures:
  • The proportion of patients that will need 5 injections (loading phase excluded) or less with ranibizumab [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: February 2008
Study Completion Date: February 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00599222

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

Additional Information:
Hospital homepage  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Anders Kvanta, Professor, St. Erik Eye Hospital
ClinicalTrials.gov Identifier: NCT00599222     History of Changes
Other Study ID Numbers: LUTA001
Study First Received: January 10, 2008
Last Updated: November 21, 2011
Health Authority: Sweden: Medical Products Agency

Keywords provided by St. Erik Eye Hospital:
AMD
macular degeneration
anti-VEGF
laser treatment

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2013