Ranibizumab and Reduced Fluence PDT for AMD (NCT00527475) | Clinical Trial Compass
CompletedPhase 2
Ranibizumab and Reduced Fluence PDT for AMD
United States60 participantsStarted 2007-05
Plain-language summary
Single agent anti-VEGF therapies such as ranibizumab have shown great promise and have set the standard for visual outcomes in treating wet macular degeneration. However, they need to be administered frequently by intraocular injections with the attendant risk of endophthalmitis, lens damage, retinal detachment, and vitreous hemorrhage. The purpose of this trial is to see if using photodynamic therapy in combination with ranibizumab will decrease the number of treatments with ranibizumab.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Willingness to sign informed consent.
✓. Age greater than 50.
✓. Evidence of macular degeneration in the form of drusen in either eye.
✓. Visual acuity of 20/25 to 20/800.
✓. Subfoveal choroidal neovascularization. Both occult and classic subtypes will be allowed. If lesion is purely occult there has to be one of the following:
✓. Recent loss of vision (5 letters on ETDRS or doubling of visual angle by snellen)
✓. Documented enlargement of lesion on FA
✓. Increase of 50 microns or more in the central subfield on OCT
Exclusion criteria
✕. Myopia, ocular histoplasmosis, or other retinal pathology that could affect vision
✕. Previous treatment of the enrolled eye for CNV
✕. Intraocular surgery within 6 weeks of enrollment
✕. Geographic atrophy, subretinal fibrosis, or pigment epithelial tear involving the fovea of the eligible eye
✕. Known hypersensitivity to verteporfin
✕. Medical condition that would preclude regular follow-up for one year.
What they're measuring
1
The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months.