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

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

Tracking Information

• First Submitted Date: January 10, 2008
• First Posted Date: January 23, 2008
• Last Update Posted Date: November 22, 2011
• Study Start Date: February 2008
• Actual Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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 (submitted: January 10, 2008): The proportion of patients that will need 5 injections (loading phase excluded)or less with ranibizumab [ Time Frame: 1 year ]

Current Secondary Outcome Measures (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 (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: The Ranibizumab Plus Transpupillary Thermotherapy for Neovascular Age-Related Macular Degeneration (AMD) Study
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Neovascular Age-related Macular Degeneration

Intervention

• Biological: ranibizumab
  0.5 mg intravitreal injection
  Other Name: Lucentis
• Procedure: TTT
  Transpupillary thermotherapy (TTT)
• Procedure: Sham TTT
  Sham Transpupillary thermotherapy (TTT)

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 10, 2008): 100
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: February 2010
• Actual Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Sweden

Administrative Information

• NCT Number: NCT00599222
• Other Study ID Numbers: LUTA001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Anders Kvanta, St. Erik Eye Hospital
• Study Sponsor: Anders Kvanta
• Collaborators: Not Provided

Investigators

• Principal Investigator: Anders Kvanta; St Eriks Eye Hospital

• PRS Account: St. Erik Eye Hospital
• Verification Date: November 2011