Ranibizumab and Reduced Fluence PDT for AMD

Completed · Phase 2

Conditions studied: Macular Degeneration

In brief

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.

Key facts

Study ID

NCT00527475

Run by

Texas Retina Associates

People needed

60

Starts

2007-05-01

Expected to finish

2010-01-01

Last updated by the study team

2025-11-28

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• New blood
• Total active lesion must be less than 12 disc areas in size. -

You may not qualify if…

• 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.
• Previous vitrectomy
• Media opacities limiting visual acuity, retinal examination, or retinal imaging.
• A lesion where > 50% of the lesion is a pigment epithelial detachment. -

Where it is running

• California Retina Consultants & Research Foundation — Santa Barbara, California, United States
• Associated Retinal Consultants — Ann Arbor, Michigan, United States
• Texas Retina Associates — Arlington, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.