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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADX-2191 (intravitreal methotrexate 0.8%) | Experimental | ADX-2191 (intravitreal methotrexate 0.8%) administered over 16 weeks. |
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| Standard surgical care procedure | Active Comparator | Standard procedure performed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Recurrent Retinal Detachment Compared to Historical Rates | Percentage of subjects with recurrent retinal detachments requiring reoperation compared to historical rates | Efficacy assessment period (Week 1 to Week 24) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Recurrent Retinal Detachment | Number of subjects with recurrent retinal detachment due to proliferative vitreoretinopathy | Efficacy assessment period (Week 1 to Week 24) |
| Best-corrected Visual Acuity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Consultants of Arizona | Phoenix | Arizona | 85053 | United States | ||
| University of California Los Angeles |
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| ID | Title | Description |
|---|---|---|
| FG000 | ADX-2191 | ADX-2191 (intravitreal methotrexate 0.8%) injected thirteen times over sixteen weeks |
| FG001 | Standard Surgical Care | Standard surgical care performed |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 5, 2021 |
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| Standard surgical care procedure | Other | Standard surgical care performed upon completion of pars plana vitrectomy |
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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).
| 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 | Week 24 |
| Intraocular Pressure Less Than 5 mmHg for Study Eye | Number of subjects with intraocular pressure less than 5 mmHg for study eye | Week 24 |
| Central Macular Subfield Thickness | Number of subjects with central macular subfield thickness assessed by spectral domain optical coherence tomography for study eye | Week 24 |
| Los Angeles |
| California |
| 90095 |
| United States |
| Florida Retina Institute | Orlando | Florida | 32806 | United States |
| Bascom Palmer Eye Institute | Palm Beach Gardens | Florida | 33418 | United States |
| Emory Eye Center | Atlanta | Georgia | 30322 | United States |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States |
| Illinois Retina Associates | Joliet | Illinois | 60435 | United States |
| University of Iowa | Iowa City | Iowa | 52242 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Ophthalmic Consultants of Boston | Boston | Massachusetts | 02114 | United States |
| Massachusetts Eye and Ear | Boston | Massachusetts | 02214 | United States |
| New England Retina Consultants | Springfield | Massachusetts | 01107 | United States |
| Kresge Eye Institute | Detroit | Michigan | 48201 | United States |
| Associated Retinal Consultants | Royal Oak | Michigan | 48073 | United States |
| Vitreo-Retinal Surgery | Minneapolis | Minnesota | 55432 | United States |
| Mayo Clinic Ophthalmology | Rochester | Minnesota | 55905 | United States |
| The Retina Institute | St Louis | Missouri | 63128 | United States |
| Long Island VitreoRetinal Consultants | Forest Hills | New York | 11375 | United States |
| Duke Health Center | Durham | North Carolina | 27705 | United States |
| OHSU Casey Eye Institute | Portland | Oregon | 97239 | United States |
| Mid Atlantic Retina | Philadelphia | Pennsylvania | 19107 | United States |
| Retina Consultants of Houston | Houston | Texas | 77030 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Safety population
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| ID | Title | Description |
|---|---|---|
| BG000 | ADX-2191 | ADX-2191 (intravitreal methotrexate 0.8%) injected thirteen times over sixteen |
| BG001 | Standard Surgical Care | Standard surgical care performed |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Recurrent Retinal Detachment Compared to Historical Rates | Percentage of subjects with recurrent retinal detachments requiring reoperation compared to historical rates | Modified Intent-to-treat population | Posted | Number | percentage of subjects | Efficacy assessment period (Week 1 to Week 24) |
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| Secondary | Number of Subjects With Recurrent Retinal Detachment | Number of subjects with recurrent retinal detachment due to proliferative vitreoretinopathy | Modified Intent-to-treat population | Posted | Count of Participants | Participants | Efficacy assessment period (Week 1 to Week 24) |
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| Secondary | 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). | Modified Intent-to-treat population | Posted | Mean | Standard Deviation | correct letters | Efficacy assessment period (Week 1 to Week 24) |
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| Secondary | Macular Epiretinal Membrane | Number of subjects with macular epiretinal membrane assessed by spectral domain optical coherence tomography for study eye | Modified Intent-to-treat population | Posted | Count of Participants | Participants | Week 24 |
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| Secondary | Intraocular Pressure Less Than 5 mmHg for Study Eye | Number of subjects with intraocular pressure less than 5 mmHg for study eye | Modified Intent-to-treat population | Posted | Count of Participants | Participants | Week 24 |
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| Secondary | Central Macular Subfield Thickness | Number of subjects with central macular subfield thickness assessed by spectral domain optical coherence tomography for study eye | Modified Intent-to-treat population | Posted | Mean | Standard Deviation | microns | Week 24 |
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The safety assessment period was up to twenty-four weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ADX-2191 | ADX-2191 (intravitreal methotrexate 0.8%) injected thirteen times over sixteen weeks | 0 | 68 | 0 | 68 | 39 | 68 |
| EG001 | Standard Surgical Care | Standard surgical care performed | 0 | 38 | 1 | 38 | 24 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Punctate keratitis | Eye disorders | Systematic Assessment |
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| Eye pain | Eye disorders | Systematic Assessment |
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| Keratitis | Eye disorders | Systematic Assessment |
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| Cystoid macular oedema | Eye disorders | Systematic Assessment |
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| Eye irritation | Eye disorders | Systematic Assessment |
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| Cataract | Eye disorders | Systematic Assessment |
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| Cataract subcapsular | Eye disorders | Systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | Systematic Assessment |
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| Corneal oedema | Eye disorders | Systematic Assessment |
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| Dry eye | Eye disorders | Systematic Assessment |
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| Macular fibrosis | Eye disorders | Systematic Assessment |
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| Vision blurred | Eye disorders | Systematic Assessment |
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| Anterior chamber inflammation | Eye disorders | Systematic Assessment |
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| Macular Oedema | Eye disorders | Systematic Assessment |
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| Corneal epithelium defect | Eye disorders | Systematic Assessment |
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| Anterior chamber cell | Eye disorders | Systematic Assessment |
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| Hypotony of eye | Eye disorders | Systematic Assessment |
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| Iris adhesions | Eye disorders | Systematic Assessment |
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| Retinal haemorrhage | Eye disorders | Systematic Assessment |
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| Anterior chamber fibrin | Eye disorders | Systematic Assessment |
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| Eye pruritus | Eye disorders | Systematic Assessment |
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| Posterior capsule opacification | Eye disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Foreign body in eye | Injury, poisoning and procedural complications | Systematic Assessment |
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| Hyphaema | Injury, poisoning and procedural complications | Systematic Assessment |
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| Post procedural inflammation | Injury, poisoning and procedural complications | Systematic Assessment |
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| Intraocular pressure increased | Investigations | Systematic Assessment |
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| Blood pressure increased | Investigations | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Aldeyra Therapeutics, Inc. | 781-257-3063 | bcavanagh@aldeyra.com |
| Jun 17, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D018630 | Vitreoretinopathy, Proliferative |
| D012163 | Retinal Detachment |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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