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X-82 to Treat Age-related Macular Degeneration

Primary Purpose

Age-Related Macular Degeneration (AMD), Macular Degeneration, Exudative Age-related Macular Degeneration

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
X-82
Anti-VEGF
Placebo
Sponsored by
Tyrogenex
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration (AMD) focused on measuring Vascular Endothelial Growth Factor (VEGF), Platelet Derived Growth Factor (PDGF), AMD

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

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

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

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

Placebo plus ivt anti-VEGF prn

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
January 21, 2015
Last Updated
February 9, 2022
Sponsor
Tyrogenex
Collaborators
SynteractHCR, International Drug Development Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02348359
Brief Title
X-82 to Treat Age-related Macular Degeneration
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis found study had achieved primary objective
Study Start Date
March 16, 2015 (Actual)
Primary Completion Date
December 12, 2017 (Actual)
Study Completion Date
January 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tyrogenex
Collaborators
SynteractHCR, International Drug Development Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration (AMD), Macular Degeneration, Exudative Age-related Macular Degeneration, AMD, Macular Degeneration, Age-related, 10, Eye Diseases, Retinal Degeneration, Retinal Diseases
Keywords
Vascular Endothelial Growth Factor (VEGF), Platelet Derived Growth Factor (PDGF), AMD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
157 (Actual)

8. Arms, Groups, and Interventions

Arm Title
50 mg of X-82 plus ivt anti-VEGF prn
Arm Type
Experimental
Arm 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.
Arm Title
100 mg of X-82 plus ivt anti-VEGF prn
Arm Type
Experimental
Arm 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.
Arm Title
200 mg of X-82 plus ivt anti-VEGF prn
Arm Type
Experimental
Arm 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.
Arm Title
Placebo plus ivt anti-VEGF prn
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
X-82
Other Intervention Name(s)
X-82 tablets
Intervention Type
Drug
Intervention Name(s)
Anti-VEGF
Other Intervention Name(s)
Aflibercept (Eylea), Ranibizumab (Lucentis), Bevacizumab (Avastin)
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Mean Change in Visual Acuity Score From Day -1 to Week52
Description
The primary outcome is the change in the visual acuity score from Day -1 to 52 weeks after randomization.
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel E Salazar, PhD
Organizational Affiliation
Study PI
Official's Role
Principal Investigator
Facility Information:
City
Tucson
State/Province
Arizona
Country
United States
City
Beverly Hills
State/Province
California
Country
United States
City
Huntington Beach
State/Province
California
Country
United States
City
Redlands
State/Province
California
Country
United States
City
Sacramento
State/Province
California
Country
United States
City
Colorado Springs
State/Province
Colorado
Country
United States
City
Golden
State/Province
Colorado
Country
United States
City
New London
State/Province
Connecticut
Country
United States
City
Fort Myers
State/Province
Florida
Country
United States
City
Lakeland
State/Province
Florida
Country
United States
City
Melbourne
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Palm Beach Gardens
State/Province
Florida
Country
United States
City
Augusta
State/Province
Georgia
Country
United States
City
Lemont
State/Province
Illinois
Country
United States
City
Oak Forest
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Glen Burnie
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Springfield
State/Province
Massachusetts
Country
United States
City
Portsmouth
State/Province
New Hampshire
Country
United States
City
Bloomfield
State/Province
New Jersey
Country
United States
City
Albany
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Asheville
State/Province
North Carolina
Country
United States
City
Charlotte
State/Province
North Carolina
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Youngstown
State/Province
Ohio
Country
United States
City
Nashville
State/Province
Tennessee
Country
United States
City
Abilene
State/Province
Texas
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
The Woodlands
State/Province
Texas
Country
United States
City
Richmond
State/Province
Virginia
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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X-82 to Treat Age-related Macular Degeneration

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