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

• 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 procedure (Other): Standard surgical care performed upon completion of pars plana vitrectomy

Primary outcomes

• Recurrent Retinal Detachment Compared to Historical Rates [Efficacy assessment period (Week 1 to Week 24)]: Percentage of subjects with recurrent retinal detachments requiring reoperation compared to historical rates

Secondary outcomes

• Number of Subjects With Recurrent Retinal Detachment [Efficacy assessment period (Week 1 to Week 24)]: Number of subjects with recurrent retinal detachment due to proliferative vitreoretinopathy
• Best-corrected Visual Acuity [Efficacy assessment period (Week 1 to Week 24)]: 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).
• Macular Epiretinal Membrane [Week 24]: Number of subjects with macular epiretinal membrane assessed by spectral domain optical coherence tomography for study eye
• Intraocular Pressure Less Than 5 mmHg for Study Eye [Week 24]: Number of subjects with intraocular pressure less than 5 mmHg for study eye
• Central Macular Subfield Thickness [Week 24]: Number of subjects with central macular subfield thickness assessed by spectral domain optical coherence tomography for study eye

Sex: All, ages: 18 Years to any

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

Participant flow

Outcome results

• Recurrent Retinal Detachment Compared to Historical Rates (Primary), Number, percentage of subjects: ADX-2191 18.8; Standard Surgical Care 20.6
• Number of Subjects With Recurrent Retinal Detachment (Secondary), Count of participants, Participants: ADX-2191 12; Standard Surgical Care 7
• Best-corrected Visual Acuity (Secondary), Mean, correct letters: ADX-2191 16.9 +/- 23.2; Standard Surgical Care 22.5 +/- 27.4
• Macular Epiretinal Membrane (Secondary), Count of participants, Participants: ADX-2191 18; Standard Surgical Care 12
• Intraocular Pressure Less Than 5 mmHg for Study Eye (Secondary), Count of participants, Participants: ADX-2191 2; Standard Surgical Care 4
• Central Macular Subfield Thickness (Secondary), Mean, microns: ADX-2191 384.4 +/- 185.24; Standard Surgical Care 473.7 +/- 228.95

Adverse events

Time frame: The safety assessment period was up to twenty-four weeks.

Serious adverse events by term

Other adverse events by term

• Study Protocol and Statistical Analysis Plan (PDF, 2021-05-05)