X-82 to Treat Age-related Macular Degeneration



Status:Terminated
Conditions:Ocular, Ocular, Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:7/27/2018
Start Date:March 16, 2015
End Date:January 12, 2018

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A Randomized, Double-Masked, Placebo-Controlled, Dose- Finding, Non-Inferiority Study of X-82 Plus Prn Intravitreal (Ivt) Anti-VEGF Compared to Prn Ivt Anti-VEGF Monotherapy in Neovascular AMD

The purpose of this study is to evaluate the safety and efficacy of X-82 in the treatment of
vision loss due to wet AMD.

Subjects will be randomized in a 1:1:1:1 ratio to the following dose groups:

- X-82 50 mg plus ivt anti-VEGF prn

- X-82 100 mg plus ivt anti-VEGF prn

- X-82 200 mg plus ivt anti-VEGF prn

- Placebo plus ivt anti-VEGF prn

Subjects will be treated for a total of 52 weeks with one of three doses of X-82 or placebo.

Primary Efficacy Outcome:

The primary efficacy outcome is the change in visual acuity score from Day -1 to 52 Weeks
after randomization.

Safety Outcomes:

Systemic and ocular safety will be evaluate by assessing ECG, laboratory analyses, adverse
events and serious adverse events.

Approximately 132 subjects will be randomized into one of the four arms (33 subjects per dose
group).

Inclusion Criteria:

- Participants mush have wet AMD which has been diagnosed and treated with anti-VEGF in
one or both eyes for at least 6 months prior to joining the study and has required at
least two prior injections of intravitreal (ivt) anti-VEGF at intervals of not greater
than 6 weeks for the past two injections in the eye that is selected to be the study
eye.

- Must have demonstrated a reduction in macular fluid or macular thickness in the study
eye 14 days following an anti-VEGF injection at Screening Visit 1

- Early Treatment Diabetic Retinopathy (ETDRS) Best Corrected Visual Acuity (BCVA) of 25
letters (20/320) or better in both eyes

Exclusion Criteria:

- Previous vitrectomy to the study eye within 30 days of Screening Visit 1

- Choroidal neovascularization (CNV) due to causes other than AMD

- Proliferative diabetic retinopathy in either eye
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