X-82 to Treat Age-related Macular Degeneration

Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02348359
• Other study ID #: X82-OPH-201
• Status: Terminated
• Phase: Phase 2
• Start date: March 16, 2015
• Est. completion date: January 12, 2018

Study information

• Verified date: February 2022
• Source: Tyrogenex
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 157
• Est. completion date: January 12, 2018
• Est. primary completion date: December 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• X-82

• Anti-VEGF

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Tyrogenex	International Drug Development Institute, SynteractHCR

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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