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The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy

Primary Purpose

Proliferative Vitreoretinopathy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ADX-2191 (intravitreal methotrexate 0.8%)
Standard surgical care procedure
Sponsored by
Aldeyra Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Proliferative Vitreoretinopathy focused on measuring ADX-2191, recurrent retinal detachment, open globe injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject is 18 years or older of any gender or race
  2. Subject is undergoing pars plana vitrectomy due to recurrent retinal detachment due to proliferative vitreoretionapthy or open globe injury
  3. Subject is willing and able to provide written informed consent, comply with clinical trial procedures, and return for all clinical trial visits
  4. Subjects of childbearing potential must agree to use two forms of birth control for the duration of the clinical trial

Exclusion Criteria:

  1. History of severe non-proliferative or proliferative diabetic retinopathy
  2. Other planned eye surgery during the course of the trial
  3. Participation in a clinical trial with an investigational medicinal product or investigational device within 90 days of subject enrollment

Sites / Locations

  • Retinal Consultants of Arizona
  • University of California Los Angeles
  • Florida Retina Institute
  • Bascom Palmer Eye Institute
  • Emory Eye Center
  • University of Illinois at Chicago
  • Illinois Retina Associates
  • University of Iowa
  • Tufts Medical Center
  • Ophthalmic Consultants of Boston
  • Massachusetts Eye and Ear
  • New England Retina Consultants
  • Kresge Eye Institute
  • Associated Retinal Consultants
  • Vitreo-Retinal Surgery
  • Mayo Clinic Ophthalmology
  • The Retina Institute
  • Long Island VitreoRetinal Consultants
  • Duke Health Center
  • OHSU Casey Eye Institute
  • Mid Atlantic Retina
  • Retina Consultants of Houston
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ADX-2191 (intravitreal methotrexate 0.8%)

Standard surgical care procedure

Arm Description

ADX-2191 (intravitreal methotrexate 0.8%) administered over 16 weeks.

Standard procedure performed.

Outcomes

Primary Outcome Measures

Recurrent retinal detachment

Secondary Outcome Measures

Best-corrected visual acuity (BCVA) change from baseline

Full Information

First Posted
October 21, 2019
Last Updated
May 31, 2023
Sponsor
Aldeyra Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04136366
Brief Title
The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy
Official Title
The GUARD Trial - Part 1: A Phase 3 Clinical Trial of Repeated Intravitreal Injections of ADX-2191 Versus Standard-of-Care for Prevention of Proliferaivie Vitreoretinopathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
June 14, 2022 (Actual)
Study Completion Date
June 14, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aldeyra Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The GUARD Trial is a multi-center, randomized, controlled, adaptive Phase 3 clinical trial of repeated intravitreal injections of ADX-2191 versus standard-of-care for the prevention of proliferative vitreoretinopathy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proliferative Vitreoretinopathy
Keywords
ADX-2191, recurrent retinal detachment, open globe injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ADX-2191 (intravitreal methotrexate 0.8%)
Arm Type
Experimental
Arm Description
ADX-2191 (intravitreal methotrexate 0.8%) administered over 16 weeks.
Arm Title
Standard surgical care procedure
Arm Type
Active Comparator
Arm Description
Standard procedure performed.
Intervention Type
Drug
Intervention Name(s)
ADX-2191 (intravitreal methotrexate 0.8%)
Intervention Description
ADX-2191 (intravitreal methotrexate 0.8%) injected 13 times over 16 weeks upon completion of pars plana vitrectomy
Intervention Type
Other
Intervention Name(s)
Standard surgical care procedure
Intervention Description
Standard surgical care performed upon completion of pars plana vitrectomy
Primary Outcome Measure Information:
Title
Recurrent retinal detachment
Time Frame
Efficacy assessment period (Week 1 to Week 24)
Secondary Outcome Measure Information:
Title
Best-corrected visual acuity (BCVA) change from baseline
Time Frame
Efficacy assessment period (Week 1 to Week 24)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is 18 years or older of any gender or race Subject is undergoing pars plana vitrectomy due to recurrent retinal detachment due to proliferative vitreoretionapthy or open globe injury Subject is willing and able to provide written informed consent, comply with clinical trial procedures, and return for all clinical trial visits Subjects of childbearing potential must agree to use two forms of birth control for the duration of the clinical trial Exclusion Criteria: History of severe non-proliferative or proliferative diabetic retinopathy Other planned eye surgery during the course of the trial Participation in a clinical trial with an investigational medicinal product or investigational device within 90 days of subject enrollment
Facility Information:
Facility Name
Retinal Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Florida Retina Institute
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Bascom Palmer Eye Institute
City
Palm Beach Gardens
State/Province
Florida
ZIP/Postal Code
33418
Country
United States
Facility Name
Emory Eye Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Illinois Retina Associates
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Massachusetts Eye and Ear
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02214
Country
United States
Facility Name
New England Retina Consultants
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Kresge Eye Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Associated Retinal Consultants
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Vitreo-Retinal Surgery
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Mayo Clinic Ophthalmology
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
The Retina Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Long Island VitreoRetinal Consultants
City
Forest Hills
State/Province
New York
ZIP/Postal Code
11375
Country
United States
Facility Name
Duke Health Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
OHSU Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Mid Atlantic Retina
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Retina Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy

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