TTT Versus PDT for Treatment of Choroidal Neovascularization in Age-Related Macular Degeneration
Transpupillary Thermotherapy Versus Photodynamic Therapy Treatment of Occult and Minimally Classic Choroidal Neovascularization in Age-Related Macular Degeneration.
2 other identifiers
interventional
140
1 country
1
Brief Summary
The purpose of the study is to compare photodynamic therapy to transpupillary thermotherapy as a treatment method for choroidal neovascularization in age-related macular degeneration ( AMD). AMD is a disease affecting the macula, the central area of the retina.There are two main types of AMD. Geographic atrophy ( dry) AMD and neovascular ( wet) AMD. In neovascular AMD, sub-retinal neovascular membranes ( new blood vessels) develop beneath the retina. The new vessels can leak causing haemorrhage that leads to significant visual loss. Photodynamic therapy ( PDT) is a method for treating neovascular membranes without affecting the retina. Photoactive chemicals are injected into the patient and irradiated with light as the pass through the neovascular membranes. This light is strong enough to activate the chemicals, that destroy the blood vessels, but not strong enough to cause damage to the overlying retina. The duration of the treatment is 83s. PDT treatment is effective in predominantly classic subfoveal choroidal neovascularization ( CNV), but was observed to yield no visual benefit in minimally classic CNV during a 2-year follow-up and as to occult CNV the effect was scarce. PDT does have its drawbacks, one of which is the cost. Another is that the patient become highly sensitive to strong light. Transpupillary thermotherapy ( TTT) is a thermic treatment of choroidal neovascularization in AMD. Using a thermal diode laser ( emission 810 nm), transpupillary irradiation of the fundus through a conventinal contact lens is performed. The temperature is elevated \< 10 degrees C during a 60s exposure to continuous radiation. The laser power is adjusted to the diameter of the laser beam. In a pilot study, Reichel et al. ( 1999) demonstrated that subfoveal occult CNV could be occluded and visual acuity stabilized in a majority of patients treated with TTT. These results has been confirmed in small series of cases with occult CNV and with minimally ( \<50%) classic CNV. This prospective, randomized controlled study aim to compare TTT and PDT as a treatment for occult and minimally classic CNV. A total of 140 patients will be included in the study. Follow up is 2 years. The patients included will be followed as to visual acutiy ( ETDRS), new vessel growth ( fluorescien angiography and ICG), OCT and with a quality of life questionnarie.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2003
Typical duration for phase_2
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
Study Start
First participant enrolled
June 1, 2003
CompletedFirst Submitted
Initial submission to the registry
November 29, 2005
CompletedFirst Posted
Study publicly available on registry
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedFebruary 3, 2006
June 1, 2004
November 29, 2005
February 2, 2006
Conditions
Outcome Measures
Primary Outcomes (1)
Visual acuity, base, 6 weeks, 3 months, 4,5 months, 6 months, 9 months, 12 months, 18 months, 24 months.
Secondary Outcomes (2)
New vessel growth
Retinal thickness
Interventions
Eligibility Criteria
You may qualify if:
- \< 25% subretinal fibrosis. No contraindications to fluoresceinangiography and ICG.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St Eriks Eye Hospital
Stockholm, 16773, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anne C Odergren, MD
St Eriks Eye Hospital
- STUDY CHAIR
Stefan Seregard, Professor
St Eriks Eye Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 29, 2005
First Posted
December 1, 2005
Study Start
June 1, 2003
Study Completion
January 1, 2008
Last Updated
February 3, 2006
Record last verified: 2004-06