X-82 to Treat Age-related Macular Degeneration

Phase 2

Terminated

• Conditions: Age-Related Macular Degeneration (AMD); Macular Degeneration, Age-related, 10; Eye Diseases; Retinal Degeneration; Macular Degeneration; Exudative Age-related Macular Degeneration; Retinal Diseases; AMD
• Interventions: Drug: X-82; Drug: Placebo; Drug: Anti-VEGF

• Registration Number: NCT02348359
• Lead Sponsor: Tyrogenex

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).

Study Timeline

• Study First Submitted: 2015-01-21
• Study First Submitted QC: 2015-01-21
• Study First Posted: 2015-01-28
• Study Start: 2015-03-16
• Primary Completion: 2017-12-12
• Study Completion: 2018-01-12
• Results First Submitted: 2018-05-30
• Results First Submitted QC: 2018-05-30
• Results First Posted: 2018-06-27
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-09
• Last Update Posted: 2022-02-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 157

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
100 mg of X-82 plus ivt anti-VEGF prn	X-82	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.
Placebo plus ivt anti-VEGF prn	Placebo	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.
50 mg of X-82 plus ivt anti-VEGF prn	Anti-VEGF	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.
100 mg of X-82 plus ivt anti-VEGF prn	Anti-VEGF	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.
50 mg of X-82 plus ivt anti-VEGF prn	X-82	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.
200 mg of X-82 plus ivt anti-VEGF prn	X-82	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.
Placebo plus ivt anti-VEGF prn	Anti-VEGF	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.
200 mg of X-82 plus ivt anti-VEGF prn	Anti-VEGF	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.

Primary Outcome Measures

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