The objective of this study is to evaluate the safety and preliminary biologic activity/efficacy of X-82 in patients with wet Age-related Macular Degeneration (AMD). Preliminary efficacy will be assessed by change from baseline in visual acuity, fluorescein leakage, retinal thickness and fibrosis, if detectable, based on fundus examination, fundus photography, fluorescein angiography and optical coherence tomography (OCT).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
35
X-82 oral for 24 weeks or until unacceptable toxicity develops
Rescue treatment with intravitreal ranibizumab (Lucentis) as needed
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States
New England Retina Associates
New London, Connecticut, United States
Elman Retina Group
Baltimore, Maryland, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Change From Baseline Visual Acuity at 6 Months
The best corrected visual acuity by the Early Treatment Diabetic Retinopathy Study (ETDRS) method was determined at baseline and at various times during the study. The ETDRS method records the number of letters of decreasing size on a chart that a subject can read from a defiend distance. During the study the ETDRS visual acuity was used to monitor the need for rescue therapy. The primary endpoint of the study was the change from baseline visual ETDRS visual acuity at 6 months. It was calculated by subtracting the baseline visual acuity from the visual acuity at 6 months for each individual subject. A positive change from baseline indicates improvement in visual acuity.
Time frame: 6 months
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Retina Consultants of Houston
Houston, Texas, United States