Study of the Safety and Efficacy of APX3330 in Diabetic Retinopathy
NCT ID: NCT04692688
Last Updated: 2023-02-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
103 participants
INTERVENTIONAL
2021-04-08
2023-01-25
Brief Summary
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Detailed Description
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Subjects with moderately severe to severe NPDR and mild PDR will be selected for study participation and be screened for study eligibility.
The eligible eye with the highest DRSS, as assessed by the central reading center, will be designated as the study eye for the primary efficacy analysis.
If the subject meets all eligibility criteria, then the subject will be randomized into the study and receive study medication. Blood will be drawn for biomarker analysis.
The total length of subject participation is approximately 26 weeks, with 5 clinic visits, 4 telephone safety calls, and one telephone call follow-up visit.
The execution of the entire study (first subject screen through last randomized subject completed) is expected to be approximately 12 to 15 months.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
The study will have a 1:1 randomization (placebo: APX3330). Randomization will be stratified by level of disease severity (NPDR or PDR). Subjects with mild PDR will be capped at 20% for each arm.
TREATMENT
QUADRUPLE
Study Groups
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APX3330
Five 120 mg tablets will be taken by mouth as follows: 3 tablets every morning and 2 tablets every evening.
APX3330
APX3330, a small-molecule oral tablet, is a Ref-1 inhibitor that can potentially reduce proinflammatory and hypoxic signaling that contributes to several eye diseases.
Placebo
Five 120 mg tablets will be taken by mouth as follows: 3 tablets every morning and 2 tablets every evening.
Placebo
Placebo tablets are identical to APX3330 tablets except for the absence of the active pharmaceutical ingredient.
Interventions
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APX3330
APX3330, a small-molecule oral tablet, is a Ref-1 inhibitor that can potentially reduce proinflammatory and hypoxic signaling that contributes to several eye diseases.
Placebo
Placebo tablets are identical to APX3330 tablets except for the absence of the active pharmaceutical ingredient.
Eligibility Criteria
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Inclusion Criteria
2. At least one eye with DR graded at least moderately severe to severe NPDR or mild PDR (corresponding to DRSS 47, 53, or 61)
3. BCVA assessed by ETDRS protocol letters score of ≥ 60 letters (Snellen equivalent ≥ 20/63)
4. Body mass index (BMI) between 18 and 40 kg/m2, inclusive
Exclusion Criteria
1. Any prior treatment in the study eye with:
1. Focal or grid laser photocoagulation within the past year or PRP at any time
2. Systemic or intravitreal anti-VEGF agents within the last 6 months
3. Intraocular steroids including triamcinolone and dexamethasone implant within the last 6 months
4. Fluocinolone implant within the last 3 years
2. Active uveitis, vitritis, or infection in either eye including infectious conjunctivitis, keratitis, scleritis, or endophthalmitis.
3. Ocular incisional surgery including cataract surgery in the study eye within 3 months.
4. Clinically significant ocular disease in either eye.
5. Presence of macular or retinal vascular disease including diabetic macular edema, retinopathy from causes other than diabetes, age-related macular degeneration, pattern dystrophy, choroidal neovascularization of any cause, retinal vein occlusion, retinal artery occlusion in the study eye.
6. History of retinal detachment, full-thickness macular hole in the study eye, or idiopathic or autoimmune uveitis in either eye.
Systemic:
1. Known hypersensitivity or contraindication to study drug.
2. Any disease or medical condition that in the opinion of the Investigator would interfere with the study, prevent the subject from successfully participating in the study, or which might confound the study results.
3. Participation in any investigational study within 30 days prior to screening or planning to participate in any other investigational drug or device clinical trials within 30 days of study completion.
4. Resting HR outside the specified range (50-110 beats per minute).
5. Known to be immunocompromised or receiving immunosuppressive therapy.
6. Hypertension with resting diastolic blood pressure (BP) \> 105 mmHg or systolic BP \> 200 mmHg.
7. History of chronic liver disease or presence of elevated alanine aminotransferase (ALT) and aspartate aminotransferase (AST) consistent with such diagnosis.
8. Women of childbearing potential who are pregnant, nursing, planning a pregnancy, or not using a medically acceptable form of birth control.
18 Years
ALL
Yes
Sponsors
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Ocuphire Pharma, Inc.
INDUSTRY
Responsible Party
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Locations
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Clinical Site 9
Phoenix, Arizona, United States
Clinical Site 8
Bakersfield, California, United States
Clinical Site 5
Beverly Hills, California, United States
Clinical Site 11
Palm Desert, California, United States
Clinical Site 2
Sacramento, California, United States
Clinical Site 24
Walnut Creek, California, United States
Clinical Site 19
Miami, Florida, United States
Clinical Site 7
Winter Haven, Florida, United States
Clinical Site 6
Carmel, Indiana, United States
Clinical Site 14
Hagerstown, Maryland, United States
Clinical Site 22
Springfield, Massachusetts, United States
Clinical Site 17
Grand Blanc, Michigan, United States
Clinical Site 12
Albuquerque, New Mexico, United States
Clinical Site 15
Shirley, New York, United States
Clinical Site 20
Charlotte, North Carolina, United States
Clinical Site 1
Rapid City, South Dakota, United States
Clinical Site 18
Austin, Texas, United States
Clinical Site 16
Bellaire, Texas, United States
Clinical Site 10
Fort Worth, Texas, United States
Clinical Site 4
McAllen, Texas, United States
Clinical Site 3
San Antonio, Texas, United States
Clinical Site 23
San Antonio, Texas, United States
Clinical Site 13
Southlake, Texas, United States
Clinical Site 21
Ogden, Utah, United States
Countries
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Other Identifiers
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OPI-APXDR-201 (ZETA-1)
Identifier Type: -
Identifier Source: org_study_id
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