Study Stopped
Interim analysis found study had achieved primary objective
X-82 to Treat Age-related Macular Degeneration
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
1 other identifier
interventional
157
1 country
35
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2015
Typical duration for phase_2
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 21, 2015
CompletedFirst Posted
Study publicly available on registry
January 28, 2015
CompletedStudy Start
First participant enrolled
March 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2018
CompletedResults Posted
Study results publicly available
June 27, 2018
CompletedFebruary 11, 2022
February 1, 2022
2.7 years
January 21, 2015
May 30, 2018
February 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
50 mg of X-82 plus ivt anti-VEGF prn
EXPERIMENTALSubject 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
EXPERIMENTALSubject 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.
200 mg of X-82 plus ivt anti-VEGF prn
EXPERIMENTALSubject 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
PLACEBO COMPARATORSubject will administer two placebo tablets once daily. Subjects will be assessed for the need for retreatment with ivt anti-VEGF therapy at each visit.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tyrogenexlead
- SynteractHCRcollaborator
- International Drug Development Institutecollaborator
Study Sites (35)
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Huntington Beach, California, United States
Unknown Facility
Redlands, California, United States
Unknown Facility
Sacramento, California, United States
Unknown Facility
Colorado Springs, Colorado, United States
Unknown Facility
Golden, Colorado, United States
Unknown Facility
New London, Connecticut, United States
Unknown Facility
Fort Myers, Florida, United States
Unknown Facility
Lakeland, Florida, United States
Unknown Facility
Melbourne, Florida, United States
Unknown Facility
Miami, Florida, United States
Unknown Facility
Palm Beach Gardens, Florida, United States
Unknown Facility
Augusta, Georgia, United States
Unknown Facility
Lemont, Illinois, United States
Unknown Facility
Oak Forest, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
Glen Burnie, Maryland, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Springfield, Massachusetts, United States
Unknown Facility
Portsmouth, New Hampshire, United States
Unknown Facility
Bloomfield, New Jersey, United States
Unknown Facility
Albany, New York, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Asheville, North Carolina, United States
Unknown Facility
Charlotte, North Carolina, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Youngstown, Ohio, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Abilene, Texas, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
The Woodlands, Texas, United States
Unknown Facility
Richmond, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Vice President, Clinical and Regulatory
- Organization
- Brace Pharma Capital
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel E Salazar, PhD
Study PI
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2015
First Posted
January 28, 2015
Study Start
March 16, 2015
Primary Completion
December 12, 2017
Study Completion
January 12, 2018
Last Updated
February 11, 2022
Results First Posted
June 27, 2018
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share