Trial Outcomes & Findings for The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy (NCT NCT04136366)
NCT ID: NCT04136366
Last Updated: 2025-07-09
Results Overview
Percentage of subjects with recurrent retinal detachments requiring reoperation compared to historical rates
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
106 participants
Primary outcome timeframe
Efficacy assessment period (Week 1 to Week 24)
Results posted on
2025-07-09
Participant Flow
Participant milestones
| Measure |
ADX-2191
ADX-2191 (intravitreal methotrexate 0.8%) injected thirteen times over sixteen weeks
|
Standard Surgical Care
Standard surgical care performed
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
38
|
|
Overall Study
COMPLETED
|
52
|
32
|
|
Overall Study
NOT COMPLETED
|
16
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy
Baseline characteristics by cohort
| Measure |
ADX-2191
n=68 Participants
ADX-2191 (intravitreal methotrexate 0.8%) injected thirteen times over sixteen
|
Standard Surgical Care
n=38 Participants
Standard surgical care performed
|
Total
n=106 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
50 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=5 Participants
|
38 participants
n=7 Participants
|
106 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Efficacy assessment period (Week 1 to Week 24)Population: Modified Intent-to-treat population
Percentage of subjects with recurrent retinal detachments requiring reoperation compared to historical rates
Outcome measures
| Measure |
ADX-2191
n=64 Participants
ADX-2191 (intravitreal methotrexate 0.8%) injected thirteen times over sixteen weeks
|
Standard Surgical Care
n=34 Participants
Standard surgical care performed
|
|---|---|---|
|
Recurrent Retinal Detachment Compared to Historical Rates
|
18.8 percentage of subjects
|
20.6 percentage of subjects
|
SECONDARY outcome
Timeframe: Efficacy assessment period (Week 1 to Week 24)Population: Modified Intent-to-treat population
Number of subjects with recurrent retinal detachment due to proliferative vitreoretinopathy
Outcome measures
| Measure |
ADX-2191
n=64 Participants
ADX-2191 (intravitreal methotrexate 0.8%) injected thirteen times over sixteen weeks
|
Standard Surgical Care
n=34 Participants
Standard surgical care performed
|
|---|---|---|
|
Number of Subjects With Recurrent Retinal Detachment
|
12 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Efficacy assessment period (Week 1 to Week 24)Population: Modified Intent-to-treat population
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).
Outcome measures
| Measure |
ADX-2191
n=62 Participants
ADX-2191 (intravitreal methotrexate 0.8%) injected thirteen times over sixteen weeks
|
Standard Surgical Care
n=31 Participants
Standard surgical care performed
|
|---|---|---|
|
Best-corrected Visual Acuity
|
16.9 correct letters
Standard Deviation 23.2
|
22.5 correct letters
Standard Deviation 27.4
|
SECONDARY outcome
Timeframe: Week 24Population: Modified Intent-to-treat population
Number of subjects with macular epiretinal membrane assessed by spectral domain optical coherence tomography for study eye
Outcome measures
| Measure |
ADX-2191
n=64 Participants
ADX-2191 (intravitreal methotrexate 0.8%) injected thirteen times over sixteen weeks
|
Standard Surgical Care
n=34 Participants
Standard surgical care performed
|
|---|---|---|
|
Macular Epiretinal Membrane
|
18 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Modified Intent-to-treat population
Number of subjects with intraocular pressure less than 5 mmHg for study eye
Outcome measures
| Measure |
ADX-2191
n=64 Participants
ADX-2191 (intravitreal methotrexate 0.8%) injected thirteen times over sixteen weeks
|
Standard Surgical Care
n=34 Participants
Standard surgical care performed
|
|---|---|---|
|
Intraocular Pressure Less Than 5 mmHg for Study Eye
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Week 24Population: Modified Intent-to-treat population
Number of subjects with central macular subfield thickness assessed by spectral domain optical coherence tomography for study eye
Outcome measures
| Measure |
ADX-2191
n=64 Participants
ADX-2191 (intravitreal methotrexate 0.8%) injected thirteen times over sixteen weeks
|
Standard Surgical Care
n=34 Participants
Standard surgical care performed
|
|---|---|---|
|
Central Macular Subfield Thickness
|
384.4 microns
Standard Deviation 185.24
|
473.7 microns
Standard Deviation 228.95
|
Adverse Events
ADX-2191
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Standard Surgical Care
Serious events: 1 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ADX-2191
n=68 participants at risk
ADX-2191 (intravitreal methotrexate 0.8%) injected thirteen times over sixteen weeks
|
Standard Surgical Care
n=38 participants at risk
Standard surgical care performed
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
0.00%
0/68 • The safety assessment period was up to twenty-four weeks.
|
2.6%
1/38 • Number of events 1 • The safety assessment period was up to twenty-four weeks.
|
Other adverse events
| Measure |
ADX-2191
n=68 participants at risk
ADX-2191 (intravitreal methotrexate 0.8%) injected thirteen times over sixteen weeks
|
Standard Surgical Care
n=38 participants at risk
Standard surgical care performed
|
|---|---|---|
|
Eye disorders
Punctate keratitis
|
16.2%
11/68 • Number of events 15 • The safety assessment period was up to twenty-four weeks.
|
2.6%
1/38 • Number of events 1 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Eye pain
|
13.2%
9/68 • Number of events 9 • The safety assessment period was up to twenty-four weeks.
|
23.7%
9/38 • Number of events 10 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Keratitis
|
8.8%
6/68 • Number of events 12 • The safety assessment period was up to twenty-four weeks.
|
5.3%
2/38 • Number of events 3 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Cystoid macular oedema
|
7.4%
5/68 • Number of events 5 • The safety assessment period was up to twenty-four weeks.
|
13.2%
5/38 • Number of events 6 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Eye irritation
|
7.4%
5/68 • Number of events 7 • The safety assessment period was up to twenty-four weeks.
|
0.00%
0/38 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Cataract
|
5.9%
4/68 • Number of events 5 • The safety assessment period was up to twenty-four weeks.
|
7.9%
3/38 • Number of events 4 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Cataract subcapsular
|
5.9%
4/68 • Number of events 6 • The safety assessment period was up to twenty-four weeks.
|
2.6%
1/38 • Number of events 1 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Conjunctival haemorrhage
|
5.9%
4/68 • Number of events 4 • The safety assessment period was up to twenty-four weeks.
|
7.9%
3/38 • Number of events 3 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Corneal oedema
|
5.9%
4/68 • Number of events 4 • The safety assessment period was up to twenty-four weeks.
|
10.5%
4/38 • Number of events 4 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Dry eye
|
5.9%
4/68 • Number of events 4 • The safety assessment period was up to twenty-four weeks.
|
5.3%
2/38 • Number of events 2 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Macular fibrosis
|
5.9%
4/68 • Number of events 4 • The safety assessment period was up to twenty-four weeks.
|
15.8%
6/38 • Number of events 6 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Vision blurred
|
5.9%
4/68 • Number of events 4 • The safety assessment period was up to twenty-four weeks.
|
2.6%
1/38 • Number of events 1 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Anterior chamber inflammation
|
4.4%
3/68 • Number of events 4 • The safety assessment period was up to twenty-four weeks.
|
7.9%
3/38 • Number of events 3 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Macular Oedema
|
4.4%
3/68 • Number of events 4 • The safety assessment period was up to twenty-four weeks.
|
7.9%
3/38 • Number of events 3 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Corneal epithelium defect
|
2.9%
2/68 • Number of events 2 • The safety assessment period was up to twenty-four weeks.
|
10.5%
4/38 • Number of events 4 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Anterior chamber cell
|
1.5%
1/68 • Number of events 1 • The safety assessment period was up to twenty-four weeks.
|
10.5%
4/38 • Number of events 6 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Hypotony of eye
|
1.5%
1/68 • Number of events 1 • The safety assessment period was up to twenty-four weeks.
|
5.3%
2/38 • Number of events 2 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Iris adhesions
|
1.5%
1/68 • Number of events 1 • The safety assessment period was up to twenty-four weeks.
|
5.3%
2/38 • Number of events 2 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Retinal haemorrhage
|
1.5%
1/68 • Number of events 1 • The safety assessment period was up to twenty-four weeks.
|
5.3%
2/38 • Number of events 2 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Anterior chamber fibrin
|
0.00%
0/68 • The safety assessment period was up to twenty-four weeks.
|
5.3%
2/38 • Number of events 2 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/68 • The safety assessment period was up to twenty-four weeks.
|
5.3%
2/38 • Number of events 2 • The safety assessment period was up to twenty-four weeks.
|
|
Eye disorders
Posterior capsule opacification
|
0.00%
0/68 • The safety assessment period was up to twenty-four weeks.
|
5.3%
2/38 • Number of events 4 • The safety assessment period was up to twenty-four weeks.
|
|
Nervous system disorders
Headache
|
7.4%
5/68 • Number of events 6 • The safety assessment period was up to twenty-four weeks.
|
5.3%
2/38 • Number of events 3 • The safety assessment period was up to twenty-four weeks.
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
1.5%
1/68 • Number of events 1 • The safety assessment period was up to twenty-four weeks.
|
5.3%
2/38 • Number of events 2 • The safety assessment period was up to twenty-four weeks.
|
|
Injury, poisoning and procedural complications
Hyphaema
|
1.5%
1/68 • Number of events 1 • The safety assessment period was up to twenty-four weeks.
|
5.3%
2/38 • Number of events 2 • The safety assessment period was up to twenty-four weeks.
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
1.5%
1/68 • Number of events 1 • The safety assessment period was up to twenty-four weeks.
|
13.2%
5/38 • Number of events 5 • The safety assessment period was up to twenty-four weeks.
|
|
Investigations
Intraocular pressure increased
|
2.9%
2/68 • Number of events 2 • The safety assessment period was up to twenty-four weeks.
|
21.1%
8/38 • Number of events 9 • The safety assessment period was up to twenty-four weeks.
|
|
Investigations
Blood pressure increased
|
0.00%
0/68 • The safety assessment period was up to twenty-four weeks.
|
5.3%
2/38 • Number of events 2 • The safety assessment period was up to twenty-four weeks.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/68 • The safety assessment period was up to twenty-four weeks.
|
5.3%
2/38 • Number of events 2 • The safety assessment period was up to twenty-four weeks.
|
|
Vascular disorders
Hypertension
|
0.00%
0/68 • The safety assessment period was up to twenty-four weeks.
|
5.3%
2/38 • Number of events 2 • The safety assessment period was up to twenty-four weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place