X-82 to Treat Age-related Macular Degeneration

Tyrogenex

Status and phase: Terminated; Phase 2

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

Treatments: Drug: Anti-VEGF; Drug: Placebo; Drug: X-82

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02348359

X82-OPH-201

Details and patient eligibility

About

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.

Full 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).

Enrollment: 157 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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157 participants in 4 patient groups, including a placebo group

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

Experimental group

Description:

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.

Treatment:

Drug: X-82

Drug: Anti-VEGF

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

Experimental group

Description:

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.

Treatment:

Drug: X-82

Drug: Anti-VEGF

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

Experimental group

Description:

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.

Treatment:

Drug: X-82

Drug: Anti-VEGF

Placebo plus ivt anti-VEGF prn

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Anti-VEGF