The Ranibizumab Plus Transpupillary Thermotherapy for Neovascular Age-Related Macular Degeneration (AMD) Study
A Prospective, Randomized, Controlled Study on Intravitreal Ranibizumab (Lucentis) Combined With Transpupillary Thermotherapy (TTT) for Neovascular Age-related Macular Degeneration (AMD)
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 10, 2008
CompletedFirst Posted
Study publicly available on registry
January 23, 2008
CompletedStudy Start
First participant enrolled
February 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedNovember 22, 2011
November 1, 2011
1.8 years
January 10, 2008
November 21, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The proportion of patients that will need 5 injections (loading phase excluded) or less with ranibizumab
1 year
Secondary Outcomes (2)
Proportion of patients losing less than 15 letters on the ETDRS visual acuity chart
1 year
Proportion of patients gaining more than 15 letters on the ETDRS visual acuity chart
1 year
Study Arms (2)
TTT
ACTIVE COMPARATORTTT is given every three months
Sham TTT
SHAM COMPARATORSham TTT is given every three months
Interventions
Eligibility Criteria
You may qualify if:
- patients with subfoveal neovascular AMD with either classic/predominantly classic or occult lesions
- visual acuity =\> 20/200
You may not qualify if:
- subretinal fibrosis or atrophy under the fovea
- patients previously treated for neovascular AMD in the study eye
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anders Kvantalead
Study Sites (1)
St Eriks Eye Hospital
Stockholm, 11282, Sweden
Related Publications (1)
Soderberg AC, Algvere PV, Hengstler JC, Soderberg 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.
PMID: 22241923DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anders Kvanta
St Eriks Eye Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
January 10, 2008
First Posted
January 23, 2008
Study Start
February 1, 2008
Primary Completion
November 1, 2009
Study Completion
February 1, 2010
Last Updated
November 22, 2011
Record last verified: 2011-11