X-82 to Treat Age-related Macular Degeneration

February 9, 2022 updated by: Tyrogenex

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

157

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • Beverly Hills, California, United States
      • Huntington Beach, California, United States
      • Redlands, California, United States
      • Sacramento, California, United States
    • Colorado
      • Colorado Springs, Colorado, United States
      • Golden, Colorado, United States
    • Connecticut
      • New London, Connecticut, United States
    • Florida
      • Fort Myers, Florida, United States
      • Lakeland, Florida, United States
      • Melbourne, Florida, United States
      • Miami, Florida, United States
      • Palm Beach Gardens, Florida, United States
    • Georgia
      • Augusta, Georgia, United States
    • Illinois
      • Lemont, Illinois, United States
      • Oak Forest, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Glen Burnie, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • Springfield, Massachusetts, United States
    • New Hampshire
      • Portsmouth, New Hampshire, United States
    • New Jersey
      • Bloomfield, New Jersey, United States
    • New York
      • Albany, New York, United States
      • New York, New York, United States
    • North Carolina
      • Asheville, North Carolina, United States
      • Charlotte, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Youngstown, Ohio, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Abilene, Texas, United States
      • Austin, Texas, United States
      • Houston, Texas, United States
      • The Woodlands, Texas, United States
    • Virginia
      • Richmond, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional 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
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
Other Names:
  • X-82 tablets
Drug: Anti-VEGF
Other Names:
  • Bevacizumab (Avastin)
  • Ranibizumab (Lucentis)
  • Aflibercept (Eylea)
Experimental: 100 mg of X-82 plus ivt anti-VEGF prn
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
Other Names:
  • X-82 tablets
Drug: Anti-VEGF
Other Names:
  • Bevacizumab (Avastin)
  • Ranibizumab (Lucentis)
  • Aflibercept (Eylea)
Experimental: 200 mg of X-82 plus ivt anti-VEGF prn
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
Other Names:
  • X-82 tablets
Drug: Anti-VEGF
Other Names:
  • Bevacizumab (Avastin)
  • Ranibizumab (Lucentis)
  • Aflibercept (Eylea)
Placebo Comparator: Placebo plus ivt anti-VEGF prn
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: Placebo
Drug: Anti-VEGF
Other Names:
  • Bevacizumab (Avastin)
  • Ranibizumab (Lucentis)
  • Aflibercept (Eylea)

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
Time Frame: Week 52
The primary outcome is the change in the visual acuity score from Day -1 to 52 weeks after randomization.
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tyrogenex

Collaborators

International Drug Development Institute
SynteractHCR

Investigators

  • Principal Investigator: Daniel E Salazar, PhD, Study PI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2015

Primary Completion (Actual)

December 12, 2017

Study Completion (Actual)

January 12, 2018

Study Registration Dates

First Submitted

January 21, 2015

First Submitted That Met QC Criteria

January 21, 2015

First Posted (Estimate)

January 28, 2015

Study Record Updates

Last Update Posted (Actual)

February 11, 2022

Last Update Submitted That Met QC Criteria

February 9, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • X82-OPH-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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