Proliferative VitreoretinopathyPhase 3NCT04136366
The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy
A Phase 3 study testing ADX-2191 (intravitreal methotrexate 0.8%) and Standard surgical care procedure in people with Proliferative Vitreoretinopathy, run by Aldeyra Therapeutics, Inc. at 23 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proliferative Vitreoretinopathy
- What is being tested?
- ADX-2191 (intravitreal methotrexate 0.8%) and Standard surgical care procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 23 sitesUnited States
- Study dates
- 15 Nov 2019to 14 Jun 2022
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 vitreoretinopathy 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
Who cannot join
- 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
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Emory Eye Center
Atlanta, Georgia, 30322
Tufts Medical Center
Boston, Massachusetts, 02111
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Massachusetts Eye and Ear
Boston, Massachusetts, 02214
University of Illinois at Chicago
Chicago, Illinois, 60612
Kresge Eye Institute
Detroit, Michigan, 48201
Duke Health Center
Durham, North Carolina, 27705
Long Island VitreoRetinal Consultants
Forest Hills, New York, 11375
Retina Consultants of Houston
Houston, Texas, 77030
University of Iowa
Iowa City, Iowa, 52242
Illinois Retina Associates
Joliet, Illinois, 60435
University of California Los Angeles
Los Angeles, California, 90095
Vitreo-Retinal Surgery
Minneapolis, Minnesota, 55432
Florida Retina Institute
Orlando, Florida, 32806
Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, 33418
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
Retinal Consultants of Arizona
Phoenix, Arizona, 85053
OHSU Casey Eye Institute
Portland, Oregon, 97239
Mayo Clinic Ophthalmology
Rochester, Minnesota, 55905
Associated Retinal Consultants
Royal Oak, Michigan, 48073
University of Washington
Seattle, Washington, 98104
New England Retina Consultants
Springfield, Massachusetts, 01107
The Retina Institute
St Louis, Missouri, 63128
About this study
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 Proliferative Vitreoretinopathy
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.
- Conditions
- Proliferative Vitreoretinopathy
- Being tested
- ADX-2191 (intravitreal methotrexate 0.8%), Standard surgical care procedure
- Keywords
- ADX-2191, recurrent retinal detachment, open globe injury
- Medical subject headings
- Vitreoretinopathy, Proliferative, Retinal Detachment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADX-2191 (intravitreal methotrexate 0.8%)Drug
ADX-2191 (intravitreal methotrexate 0.8%) injected 13 times over 16 weeks upon completion of pars plana vitrectomy
Standard surgical care procedureOther
Standard surgical care performed upon completion of pars plana vitrectomy
| Study group | Role | What they receive |
|---|---|---|
| ADX-2191 (intravitreal methotrexate 0.8%) | Experimental | ADX-2191 (intravitreal methotrexate 0.8%) administered over 16 weeks. Receives: Drug: ADX-2191 (intravitreal methotrexate 0.8%) |
| Standard surgical care procedure | Active comparator | Standard procedure performed. Receives: Other: Standard surgical care procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrent Retinal Detachment Compared to Historical Rates
Percentage of subjects with recurrent retinal detachments requiring reoperation compared to historical rates
Measured: Efficacy assessment period (Week 1 to Week 24)
Secondary outcomes (5)
Number of Subjects With Recurrent Retinal Detachment
Number of subjects with recurrent retinal detachment due to proliferative vitreoretinopathy
Measured: Efficacy assessment period (Week 1 to Week 24)
Best-corrected Visual Acuity
Change from baseline of best-corrected visual acuity using an early treatment diabetic retinopathy study (ETDRS) chart. The ETDRS chart contains seventy letters and the visual acuity letter score is equal to the total number of letters read correctly (0 = worst outcome, 70 = best outcome).
Measured: Efficacy assessment period (Week 1 to Week 24)
Macular Epiretinal Membrane
Number of subjects with macular epiretinal membrane assessed by spectral domain optical coherence tomography for study eye
Measured: Week 24
Intraocular Pressure Less Than 5 mmHg for Study Eye
Number of subjects with intraocular pressure less than 5 mmHg for study eye
Measured: Week 24
Central Macular Subfield Thickness
Number of subjects with central macular subfield thickness assessed by spectral domain optical coherence tomography for study eye
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start15 Nov 2019
- Primary completion14 Jun 2022
- Study completion14 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Proliferative VitreoretinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aldeyra Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136366
- Sponsor's protocol ID
- ADX-2191-PVR-001
- Status last verified
- Oct 2022
- First submitted
- 21 Oct 2019
- Last updated
- 9 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Proliferative Vitreoretinopathy
- ClinicalTrials.gov ID
- NCT04136366
- Acronym / sponsor ID
- ADX-2191-PVR-001
- Conditions
- Proliferative Vitreoretinopathy
- Keywords
- ADX-2191, recurrent retinal detachment, open globe injury
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Aldeyra Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 23 Oct 2019 (actual)
- Results
- Posted 9 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADX-2191 (intravitreal methotrexate 0.8%) | Experimental | Drug: ADX-2191 (intravitreal methotrexate 0.8%)ADX-2191 (intravitreal methotrexate 0.8%) administered over 16 weeks. |
| Standard surgical care procedure | Active comparator | Other: Standard surgical care procedureStandard procedure performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 vitreoretinopathy 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADX-2191 (intravitreal methotrexate 0.8%)ADX-2191 (intravitreal methotrexate 0.8%) injected 13 times over 16 weeks upon completion of pars plana vitrectomy | Drug | ADX-2191 (intravitreal methotrexate 0.8%) |
| Standard surgical care procedureStandard surgical care performed upon completion of pars plana vitrectomy | Other | Standard surgical care procedure |
Primary outcome
Recurrent Retinal Detachment Compared to Historical Rates
Time frame: Efficacy assessment period (Week 1 to Week 24)
Percentage of subjects with recurrent retinal detachments requiring reoperation compared to historical rates
5 secondary outcomes
Number of Subjects With Recurrent Retinal Detachment
Time frame: Efficacy assessment period (Week 1 to Week 24)
Best-corrected Visual Acuity
Time frame: Efficacy assessment period (Week 1 to Week 24)
Macular Epiretinal Membrane
Time frame: Week 24
Intraocular Pressure Less Than 5 mmHg for Study Eye
Time frame: Week 24
Central Macular Subfield Thickness
Time frame: Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ADX-2191 (intravitreal methotrexate 0.8%) and Standard surgical care procedure in people with Proliferative Vitreoretinopathy, run by Aldeyra Therapeutics, Inc. at 23 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrent Retinal Detachment Compared to Historical Rates (time frame: Efficacy assessment period (Week 1 to Week 24)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.