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

Aldeyra Therapeutics, Inc.106 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

106

Conditions

Proliferative Vitreoretinopathy

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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 vitreoretinopathy 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

Locations (23)

Retinal Consultants of Arizona

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Recurrent Retinal Detachment Compared to Historical Rates

Percentage of subjects with recurrent retinal detachments requiring reoperation compared to historical rates

Time frame: Efficacy assessment period (Week 1 to Week 24)

Secondary Outcomes

Number of Subjects With Recurrent Retinal Detachment

Number of subjects with recurrent retinal detachment due to proliferative vitreoretinopathy

Time frame: 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).

Time frame: 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

Time frame: Week 24

Intraocular Pressure Less Than 5 mmHg for Study Eye

Number of subjects with intraocular pressure less than 5 mmHg for study eye

Time frame: Week 24

Central Macular Subfield Thickness

Number of subjects with central macular subfield thickness assessed by spectral domain optical coherence tomography for study eye

Time frame: Week 24

Data from ClinicalTrials.gov

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