- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00260403
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Age-related macular degeneration ( 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, subretinal neovascular membranes develop beneath the retina. The new vessels can leak causing haemorrhage that leads to edema, scarring and significant visual loss. Sub-retinal neovasular membranes are defined as classic, occult and minimally classic according to their apperance on fluorescein angiography. Trials have shown that early laser photocoagulation of classic extrafoveal lesions could delay the loss of vision in a small number of patients. However, most patients present with subfoveal membranes and whilst photocoagulation can limit the extent of subsequent visual loss, it causes immediate loss of central vision due to concurrent destruction of the overlying retina. Photodynamic theray ( PDT) represent a milestone in the treatment of CNV, and marks the start of a new era. Current PDT operates on the basis of principal that makes use of a dye ( verteporfin) which is preferentially retained in proliferating tissue such as CNV, sensitizing the endothelial cells to laser rediation ( 689 nm). Endothelial cells degeneration is mediated by reactive oxygen which intermediates with subsequent platelet activation, and a thrombosis, and temporary or permanent occlusion of vessels is seen in the treated area ( Ghazi et al 2001. The light is strong enough to activate the chemicals, causing them to emit free radicals that destroy the blood vessles, but not strong enough to cause damage to the overlying retina. The duration of the treatment is 83s. PDT is effective in predominantly classic subfoveal CNV, but was observed to yield no visual benefit in minimally clasic CNV during a 2-year follow-up. As to occult CNV PDT was effective in small lesions ( 4 disc areas or less), when there was a recent disease progress and when visual acuity was less then 20/50. In the VIP ( Verteporfin Therapy of Subfoveal Choroidal neovascularization, 2 year resulta of Randomized Clinical trial incl Lesion with Occult with no classic CNV) the primary outcome, visual acuity, was similar for the verteporfin-treated and the placebo-treated eyes through the month 12 examination. Between the month 12 and 24 rxminations, the treatment benefit grew so that by the month 24 examination, the verteporfin-treated eyes were less likely to have moderate or severe vision loss. PDT does have its drawbacks, ont is the cost. Another that the patient become highly sensitive to strong light and needs to wear special sunglasses for 48 hrs after treatment. There has also been discussions regarding lesion size and the potential of damage due to re-treatments.
Transpupillary thermotherapy ( TTT) is a thermic teratment of CNV in AMD. Using a thermal diode laser ( emission 810nm), transpupillary irradiation of the fundus through a conventional ( laser) contact lens is performed. The irradiation is resorbed mainly in the melanin granules of RPE and choroidal melanocytes and there is little absorption in the neurosensory retina. The temperatures in the layers of RPE and choriocapillaris is elevated < 10 degrees C during a 60s exposure to continuous rediation. High rates of resportion of the radiation in the endothelium of growing, newly formed vessels will result in thrombus formation and delayed closure of the CNV. The power is adjusted to the diameter of the laser beam. Laser power of 400 mW for a 2.0 mm spot, was found to be safe for the retina in human eyes ( Conolly et al 2001). 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.
This prospective, randomized controlled study aim to compare PDT and TTT as a treatment for occult and minimally classic CNV. A total of 140 patients will be included in the study, ( 110 patients are presently included). Follow up is 2 years. The main outcome is visual acuity ( ETDRS), new vessel growth ( fluorescein angiography and ICG), retinal thickness ( OCT. Furtermore patients will participate in a quality of life questionnarie ( National Eye Institute Visual Function Questionnarie, NEI-CFQ-25).
Study Type
Enrollment
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Anne C Odergren, MD
- Phone Number: 3066 +46 8 6723000
- Email: anne.odergren@sankterik.se
Study Locations
-
-
-
Stockholm, Sweden, 16773
- Recruiting
- St Eriks Eye Hospital
-
Contact:
- Anne C Odergren, MD
- Phone Number: 3066 +46 8 6723000
- Email: anne.odergren@sankterik.se
-
Principal Investigator:
- Anne C Odergren, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Informed consent. Occult or minimally classic choroidal neovascularization. Lesion size < 5 mm. VA 0.1-0.5. Recent disease progress.
< 25% subretinal fibrosis. No contraindications to fluoresceinangiography and ICG.
-
Exclusion Criteria: Earlier treatment with argonlaser or PDT, or otherwise treated in the eye with radiation or PPV. Submacular hemorrhage > 50%. Serous PED > 25%. Geographic atrophy > 1 disc and < 500 um from fovea. Chorioretinal anastomosis. Glaucoma. Diabetes retinopathy with > 5 microaneurysm. Contraindications to fluoresceinangiography or ICG. Enrollment in other studies. Drugaddiction.
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Visual acuity, base, 6 weeks, 3 months, 4,5 months, 6 months, 9 months, 12 months, 18 months, 24 months.
|
Secondary Outcome Measures
Outcome Measure |
---|
New vessel growth
|
Retinal thickness
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne C Odergren, MD, St Eriks Eye Hospital
- Study Chair: Stefan Seregard, Professor, St Eriks Eye Hospital
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 95/00
- Dnr 2005/19-32
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Choroidal Neovascularization
-
Hospices Civils de LyonCompletedInflammatory Choroidal NeovascularizationFrance
-
Jiao MingfeiUnknownIdiopathic Choroidal NeovascularizationChina
-
Hospices Civils de LyonCompletedStudy Evaluating the Efficacy of Aflibercept for the Treatment of NVCI in Young Patients (INTUITION)Idiopathic Choroidal NeovascularizationFrance
-
Instituto de Olhos de GoianiaUnknownChoroidal Retinal NeovascularizationBrazil
-
Asociación para Evitar la Ceguera en MéxicoCentro Medico IssemymUnknownSubfoveal Choroidal NeovascularizationMexico
-
Poitiers University HospitalCompletedType 3 Choroidal NeovascularizationFrance
-
Novartis PharmaceuticalsCompletedChoroidal Neovascularization (CNV)Korea, Republic of, Germany, Russian Federation, Turkey, Australia, Hungary, Switzerland, Italy, Lithuania, Denmark, Peru, Spain, Portugal, Canada, France, Latvia, Greece, Slovakia, Czech Republic, Poland, Singapore
-
University Hospital, LimogesUnknownChoroidal Neovascularization, Visual Field, Visual AcuityFrance
-
Instituto de Olhos de GoianiaUnknown
-
Instituto de Olhos de GoianiaCompletedMyopic Choroidal NeovascularizationBrazil
Clinical Trials on Photodynamic therapy versus Transpupillary thermotherapy
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Centre Hospitalier Universitaire de NiceWithdrawnDystrophic Epidermolysis BullosaFrance
-
Maastricht Radiation OncologyUniversity of Pennsylvania; Philipps University Marburg Medical Center; University...CompletedCarcinoma, Squamous Cell of Head and NeckNetherlands
-
Northwestern UniversityCompleted
-
Bispebjerg HospitalCompletedActinic KeratosesDenmark
-
Bispebjerg HospitalCompleted
-
National Taiwan University HospitalCompleted
-
photonamic GmbH & Co. KGCompletedActinic KeratosisGermany
-
University of KansasDUSA Pharmaceuticals, Inc.CompletedHidradenitis SuppurativaUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)CompletedRecurrent Non-small Cell Lung Cancer | Stage 0 Non-small Cell Lung Cancer | Squamous Cell Lung Cancer | Adenocarcinoma of the Lung | Large Cell Lung CancerUnited States