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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

Tracking Information
First Submitted Date  ICMJE January 10, 2008
First Posted Date  ICMJE January 23, 2008
Last Update Posted Date November 22, 2011
Study Start Date  ICMJE February 2008
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
The proportion of patients that will need 5 injections (loading phase excluded) or less with ranibizumab [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 10, 2008)
The proportion of patients that will need 5 injections (loading phase excluded)or less with ranibizumab [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2009)
  • Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart [ Time Frame: 1 year ]
  • Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2008)
  • Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart. [ Time Frame: 1 year ]
  • Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart. [ Time Frame: 1 year ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Ranibizumab Plus Transpupillary Thermotherapy for Neovascular Age-Related Macular Degeneration (AMD) Study
Official Title  ICMJE A Prospective, Randomized, Controlled Study on Intravitreal Ranibizumab (Lucentis) Combined With Transpupillary Thermotherapy (TTT) for Neovascular Age-related Macular Degeneration (AMD)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neovascular Age-related Macular Degeneration
Intervention  ICMJE
  • Biological: ranibizumab
    0.5 mg intravitreal injection
    Other Name: Lucentis
  • Procedure: TTT
    Transpupillary thermotherapy (TTT)
  • Procedure: Sham TTT
    Sham Transpupillary thermotherapy (TTT)
Study Arms  ICMJE
  • Active Comparator: TTT
    TTT is given every three months
    Interventions:
    • Biological: ranibizumab
    • Procedure: TTT
  • Sham Comparator: Sham TTT
    Sham TTT is given every three months
    Interventions:
    • Biological: ranibizumab
    • Procedure: Sham TTT
Publications * Söderberg AC, Algvere PV, Hengstler JC, Söderberg 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2008)
100
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00599222
Other Study ID Numbers  ICMJE LUTA001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anders Kvanta, St. Erik Eye Hospital
Study Sponsor  ICMJE Anders Kvanta
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anders Kvanta St Eriks Eye Hospital
PRS Account St. Erik Eye Hospital
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP