X-82 to Treat Age-related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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).

Official Title
-----------------
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

Conditions
-----------------
AMD, Macular Degeneration, Age-Related Macular Degeneration (AMD), Exudative Age-related Macular Degeneration, Macular Degeneration, Age-related, 10, Eye Diseases, Retinal Degeneration, Retinal Diseases

Intervention / Treatment
-----------------
* Drug: X-82
* Drug: Anti-VEGF
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50 mg of X-82 plus ivt anti-VEGF prn<br>Subject will administer one 50 mg tablet of X-82 and one placebo tablet once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. | Drug: X-82<br> <br> * Other names: X-82 tablets;Drug: Anti-VEGF<br> <br> * Other names: Bevacizumab (Avastin);|
| Experimental: 100 mg of X-82 plus ivt anti-VEGF prn<br>Subject will administer two 50 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. | Drug: X-82<br> <br> * Other names: X-82 tablets;Drug: Anti-VEGF<br> <br> * Other names: Bevacizumab (Avastin);|
| Experimental: 200 mg of X-82 plus ivt anti-VEGF prn<br>Subject will administer two 100 mg tablets of X-82 once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. | Drug: X-82<br> <br> * Other names: X-82 tablets;Drug: Anti-VEGF<br> <br> * Other names: Bevacizumab (Avastin);|
| Placebo Comparator: Placebo plus ivt anti-VEGF prn<br>Subject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit. | Drug: Anti-VEGF<br> <br> * Other names: Bevacizumab (Avastin);Drug: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in Visual Acuity Score From Day -1 to Week52 | The primary outcome is the change in the visual acuity score from Day -1 to 52 weeks after randomization. | Week 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vascular Endothelial Growth Factor (VEGF), Platelet Derived Growth Factor (PDGF), AMD