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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04136366

Enrollment

106

Registered

2019-10-23

Start date

2019-11-15

Completion date

2022-06-14

Last updated

2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Proliferative Vitreoretinopathy

Keywords

ADX-2191, recurrent retinal detachment, open globe injury

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.

Interventions

DRUGADX-2191 (intravitreal methotrexate 0.8%)

ADX-2191 (intravitreal methotrexate 0.8%) injected 13 times over 16 weeks upon completion of pars plana vitrectomy

OTHERStandard surgical care procedure

Standard surgical care performed upon completion of pars plana vitrectomy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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 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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Participant flow

Participants by arm

Arm	Count
ADX-2191 ADX-2191 (intravitreal methotrexate 0.8%) injected thirteen times over sixteen	68
Standard Surgical Care Standard surgical care performed	38
Total	106

Baseline characteristics

Characteristic	ADX-2191	Standard Surgical Care	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0 Participants
Age, Categorical >=65 years	18 Participants	15 Participants	33 Participants
Age, Categorical Between 18 and 65 years	50 Participants	23 Participants	73 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants	3 Participants	10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	60 Participants	35 Participants	95 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	3 Participants	1 Participants	4 Participants
Race (NIH/OMB) Black or African American	5 Participants	3 Participants	8 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants	2 Participants	4 Participants
Race (NIH/OMB) White	58 Participants	32 Participants	90 Participants
Region of Enrollment United States	68 participants	38 participants	106 participants
Sex: Female, Male Female	51 Participants	24 Participants	75 Participants
Sex: Female, Male Male	17 Participants	14 Participants	31 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 68	0 / 38
other Total, other adverse events	39 / 68	24 / 38
serious Total, serious adverse events	0 / 68	1 / 38

Outcome results

Primary

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)