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CompletedNCT03197870TIME-2bUpdated Jun 27, 2023Results posted

The TIME-2b Study: A Study of AKB-9778 (Razuprotafib), a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR)

A Phase 2 interventional study of AKB-9778 and Placebo in Nonproliferative Diabetic Retinopathy, sponsored by EyePoint Pharmaceuticals, Inc.. Completed at 53 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-06-27.

Sponsored by EyePoint Pharmaceuticals, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
167
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the safety and efficacy of subcutaneously administered AKB-9778 15mg once daily or 15mg twice daily for 12 months in patients with moderate to severe non-proliferative diabetic retinopathy (NPDR).

02

Conditions studied

  • Nonproliferative Diabetic Retinopathy
03

In context

Retinal Diseases

815 studies on the registry are indexed under Retinal Diseases; 105 are open to participants now.

This study's enrollment of 167 is above the median of 60 across 500 interventional studies indexed under Retinal Diseases.

Browse Retinal Diseases studies →

Lead sponsor

EyePoint Pharmaceuticals, Inc. is the lead sponsor of 19 studies on the registry; none are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Adults 18 through 80 years of age (inclusive)
  • Subjects with moderate to very severe NPDR (ETDRS Level 43 - 53 inclusive)
  • No evidence of central involved diabetic macular edema
  • ETDRS best-corrected visual acuity letter score ≥ 70 (Snellen 20/40 or better)

Key Exclusion Criteria:

  • Ocular disease other than DR that may cause substantial reduction in visual acuity, including iris neovascularization, retinal detachment, visually significant epiretinal membrane, vitreous hemorrhage or fibrosis, ocular inflammation (uveitis), other retinal inflammatory or infectious diseases
  • Evidence of neovascularization on clinical examination or imaging
  • Hemoglobin A1C (HbA1C) ≥ 12.0% at Screening
  • Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
167 participants (actual)

Study arms

  • Experimental
    AKB-9778 15mg Daily

    AKB-9778 15 mg (QD); To maintain masking, subjects will receive BID dosing with masked study medication administered as one dose of active and one dose of matching placebo

    Drug: AKB-9778 · Drug: Placebo

  • Experimental
    AKB-9778 15mg Twice Daily

    AKB-9778 15 mg (BID)

    Drug: AKB-9778

  • Placebo comparator
    Placebo Twice Daily

    Placebo Group: SC Phosphate-Buffered-Saline (PBS) (BID)

    Drug: Placebo

Interventions

  • DrugAKB-9778

    Subcutaneous AKB-9778 15mg

  • DrugPlacebo

    Subcutaneous Placebo

06

What researchers measure

Primary outcomes

  1. Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps

    Change from baseline to Week 48 in Diabetic Retinopathy Severity Scale Score in Study Eye by visit in the modified intent-to-treat population. ETDRS DR severity levels 10-85; ETDRS Steps 1-12

    Time frame: Baseline to Week 48

Secondary outcomes

  1. Summary of Subjects With a Worsening in the Study Eye DRSS of ≥ 2 Steps at Week 48

    Worsening of Diabetic Retinopathy Severity Score (DRSS) severity of ≥ 2 steps in study eyes at Week 48 (compared to placebo group) Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR

    Time frame: Baseline to Week 48

  2. Mean Change From Baseline in DRSS in the Study Eye at Week 48

    Mean change from baseline in Diabetic Retinopathy Severity Score (DRSS) in the study eye at week 48. Note: Observed values at Week 48 instead of change from baseline values at Week 48 were analyzed Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR

    Time frame: Week 48

  3. Summary of Subjects With an Improvement or Worsening in the Study Eye DRSS of ≥ 3 Steps at Week 48.

    Summary of subjects with an improvement or worsening in the study eye Diabetic Retinopathy Severity Score (DRSS) of ≥ 3 steps at Week 48 (compared to placebo) Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR

    Time frame: Baseline to Week 48

  4. Subjects With Criterion Step Improvement in DRSS at Week 48/EOT (>=2 Steps Improvement in the Study Eye for Patients With Non-qualified Fellow Eye and >=3 Steps Improvement on the Person Scale for Patients With Qualified Fellow Eyes)

    Subjects with Criterion Step Improvement in Diabetic Retinopathy Severity Score (DRSS) at Week 48/EOT (\>=2 Steps Improvement in the Study Eye for Patients with Non-qualified Fellow Eye and \>=3 Steps Improvement on the Person Scale for Patients with Qualified Fellow Eyes). Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR

    Time frame: Treatment Period - 12 months (48 weeks)

  5. Subjects With Criterion Step Improvement in DRSS at Week 48/EOT (>=2 Steps Improvement in the Study Eye for Patients With Non-qualified Fellow Eye and >=3 Steps Improvement on the Binocular Scale for Patients With Qualified Fellow Eyes)

    Subjects With Criterion Step Improvement in Diabetic Retinopathy Severity Score (DRSS) at Week 48/EOT (\>=2 Steps Improvement in the Study Eye for Patients With Non-qualified Fellow Eye and \>=3 Steps Improvement on the Binocular Scale for Patients With Qualified Fellow Eyes). Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR

    Time frame: Treatment Period - 12 months (48 weeks)

  6. Summary of Patients Developing Center-involved DME or PDR or PDR-related Outcomes During Treatment Period Based on Clinical Data.

    Summary of patients developing center-involved Diabetic Macular Edema (DME) or Proliferative Diabetic Retinopathy (PDR) or PDR-related outcomes during treatment period based on Clinical Data. Based on either clinical data or central image reading center evaluation.

    Time frame: Treatment Period - 12 months (48 weeks)

  7. Summary of Subjects Developing Center-involved DME or PDR or Worsening of >=2 Steps DRSS at Week 48 Based on Central Image Reading Center Evaluation

    Summary of Subjects Developing Center-involved Diabetic Macular Edema (DME) or Proliferative Diabetic Retinopathy (PDR) or Worsening of \>=2 Steps Diabetic Retinopathy Severity Scale (DRSS) at Week 48 Based on Central Image Reading Center Evaluation - Study Eyes Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR

    Time frame: Treatment Period - 12 months (48 weeks)

07

Results

Posted Jun 27, 2023

Participant flow

Participant flow — Overall Study
MilestoneRazuprotafib 15mg Twice DailyRazuprotafib 15mg DailyPlacebo Twice Daily
Started555557
Completed414551
Not completed14106
Withdrew: Adverse event946
Withdrew: Withdrawal by subject230
Withdrew: Lost to follow-up220
Withdrew: Data not available110

Outcome measures

PrimaryPercentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps

Change from baseline to Week 48 in Diabetic Retinopathy Severity Scale Score in Study Eye by visit in the modified intent-to-treat population. ETDRS DR severity levels 10-85; ETDRS Steps 1-12

Time frame:
Baseline to Week 48
Reported as:
Count of units · eyes
Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps
eyesRazuprotafib 15mg Twice DailyRazuprotafib 15mg DailyPlacebo Twice Daily
Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps052
Statistical analysis
  • Razuprotafib 15mg Twice Daily · Fisher Exact · p = 0.495 (Missing data was imputed using last observation carried forward; baseline values were not carried forward.)
SecondarySummary of Subjects With a Worsening in the Study Eye DRSS of ≥ 2 Steps at Week 48

Worsening of Diabetic Retinopathy Severity Score (DRSS) severity of ≥ 2 steps in study eyes at Week 48 (compared to placebo group) Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR

Time frame:
Baseline to Week 48
Reported as:
Count of units · study eyes
Summary of Subjects With a Worsening in the Study Eye DRSS of ≥ 2 Steps at Week 48
study eyesAKB-9778 15mg DailyAKB-9778 15mg Twice DailyPlacebo Twice Daily
Summary of Subjects With a Worsening in the Study Eye DRSS of ≥ 2 Steps at Week 48564
SecondaryMean Change From Baseline in DRSS in the Study Eye at Week 48

Mean change from baseline in Diabetic Retinopathy Severity Score (DRSS) in the study eye at week 48. Note: Observed values at Week 48 instead of change from baseline values at Week 48 were analyzed Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR

Time frame:
Week 48
Reported as:
Mean · score on a scale
Mean Change From Baseline in DRSS in the Study Eye at Week 48
score on a scaleAKB-9778 15mg DailyAKB-9778 15mg Twice DailyPlacebo Twice Daily
Mean Change From Baseline in DRSS in the Study Eye at Week 485.0 ± 1.154.9 ± 1.554.8 ± 1.35
SecondarySummary of Subjects With an Improvement or Worsening in the Study Eye DRSS of ≥ 3 Steps at Week 48.

Summary of subjects with an improvement or worsening in the study eye Diabetic Retinopathy Severity Score (DRSS) of ≥ 3 steps at Week 48 (compared to placebo) Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR

Time frame:
Baseline to Week 48
Reported as:
Count of units · study eyes
Summary of Subjects With an Improvement or Worsening in the Study Eye DRSS of ≥ 3 Steps at Week 48.
study eyesAKB-9778 15mg DailyAKB-9778 15mg Twice DailyPlacebo Twice Daily
Worsening ≥3 steps343
Improvement ≥3 steps000
SecondarySubjects With Criterion Step Improvement in DRSS at Week 48/EOT (>=2 Steps Improvement in the Study Eye for Patients With Non-qualified Fellow Eye and >=3 Steps Improvement on the Person Scale for Patients With Qualified Fellow Eyes)

Subjects with Criterion Step Improvement in Diabetic Retinopathy Severity Score (DRSS) at Week 48/EOT (\>=2 Steps Improvement in the Study Eye for Patients with Non-qualified Fellow Eye and \>=3 Steps Improvement on the Person Scale for Patients with Qualified Fellow Eyes). Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR

Time frame:
Treatment Period - 12 months (48 weeks)
Reported as:
Count of participants · Participants
Subjects With Criterion Step Improvement in DRSS at Week 48/EOT (>=2 Steps Improvement in the Study Eye for Patients With Non-qualified Fellow Eye and >=3 Steps Improvement on the Person Scale for Patients With Qualified Fellow Eyes)
ParticipantsAKB-9778 15mg DailyAKB-9778 15mg Twice DailyPlacebo Twice Daily
Subjects With Criterion Step Improvement in DRSS at Week 48/EOT (>=2 Steps Improvement in the Study Eye for Patients With Non-qualified Fellow Eye and >=3 Steps Improvement on the Person Scale for Patients With Qualified Fellow Eyes)051
SecondarySubjects With Criterion Step Improvement in DRSS at Week 48/EOT (>=2 Steps Improvement in the Study Eye for Patients With Non-qualified Fellow Eye and >=3 Steps Improvement on the Binocular Scale for Patients With Qualified Fellow Eyes)

Subjects With Criterion Step Improvement in Diabetic Retinopathy Severity Score (DRSS) at Week 48/EOT (\>=2 Steps Improvement in the Study Eye for Patients With Non-qualified Fellow Eye and \>=3 Steps Improvement on the Binocular Scale for Patients With Qualified Fellow Eyes). Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR

Time frame:
Treatment Period - 12 months (48 weeks)
Reported as:
Count of participants · Participants
Subjects With Criterion Step Improvement in DRSS at Week 48/EOT (>=2 Steps Improvement in the Study Eye for Patients With Non-qualified Fellow Eye and >=3 Steps Improvement on the Binocular Scale for Patients With Qualified Fellow Eyes)
ParticipantsAKB-9778 15mg DailyAKB-9778 15mg Twice DailyPlacebo Twice Daily
Subjects With Criterion Step Improvement in DRSS at Week 48/EOT (>=2 Steps Improvement in the Study Eye for Patients With Non-qualified Fellow Eye and >=3 Steps Improvement on the Binocular Scale for Patients With Qualified Fellow Eyes)051
SecondarySummary of Patients Developing Center-involved DME or PDR or PDR-related Outcomes During Treatment Period Based on Clinical Data.

Summary of patients developing center-involved Diabetic Macular Edema (DME) or Proliferative Diabetic Retinopathy (PDR) or PDR-related outcomes during treatment period based on Clinical Data. Based on either clinical data or central image reading center evaluation.

Time frame:
Treatment Period - 12 months (48 weeks)
Reported as:
Count of units · study eyes
Summary of Patients Developing Center-involved DME or PDR or PDR-related Outcomes During Treatment Period Based on Clinical Data.
study eyesAKB-9778 15mg DailyAKB-9778 15mg Twice DailyPlacebo Twice Daily
Summary of Patients Developing Center-involved DME or PDR or PDR-related Outcomes During Treatment Period Based on Clinical Data.121010
SecondarySummary of Subjects Developing Center-involved DME or PDR or Worsening of >=2 Steps DRSS at Week 48 Based on Central Image Reading Center Evaluation

Summary of Subjects Developing Center-involved Diabetic Macular Edema (DME) or Proliferative Diabetic Retinopathy (PDR) or Worsening of \>=2 Steps Diabetic Retinopathy Severity Scale (DRSS) at Week 48 Based on Central Image Reading Center Evaluation - Study Eyes Grading will follow Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) criteria. DRSS grades ranging from 10-85 will be converted to an ordinal score ranging from 1-11. ETDRS DRSS Level 10 = No retinopathy ETDRS DRSS Level 20 = Very mild NPDR ETDRS DRSS Level 35 = Mild NPDR ETDRS DRSS Level 43 = Moderate NPDR ETDRS DRSS Level 53 = Severe NPDR ETDRS DRSS Level 61 = Mild PDR ETDRS DRSS Level 65 = Moderate PDR ETDRS DRSS Level 71-75 = High-Risk PDR ETDRS DRSS Level 81-85 = Advanced PDR

Time frame:
Treatment Period - 12 months (48 weeks)
Reported as:
Count of participants · Participants
Summary of Subjects Developing Center-involved DME or PDR or Worsening of >=2 Steps DRSS at Week 48 Based on Central Image Reading Center Evaluation
ParticipantsAKB-9778 15mg DailyAKB-9778 15mg Twice DailyPlacebo Twice Daily
Summary of Subjects Developing Center-involved DME or PDR or Worsening of >=2 Steps DRSS at Week 48 Based on Central Image Reading Center Evaluation1087

Adverse events

Collected over Adverse events were collected from Screening through the last protocol specified visit [approximately 56 weeks (Screening period up to 4 weeks, Baseline and Treatment period for 48 weeks, and Follow-up period for 4 weeks)]. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Razuprotafib 15mg Twice Daily0/55 (0%)8/55 (14.5%)55/55 (100%)
Razuprotafib 15mg Daily0/55 (0%)6/55 (10.9%)55/55 (100%)
Placebo Twice Daily1/57 (1.8%)5/57 (8.8%)57/57 (100%)
Most frequent serious events
Showing 10 of 24
Most frequent serious events
EventRazuprotafib 15mg Twice DailyRazuprotafib 15mg DailyPlacebo Twice Daily
OsteomyelitisInfections and infestations2/550/550/57
Myocardial infarctionCardiac disorders0/550/552/57
Diabetic gangreneInfections and infestations0/551/550/57
InfluenzaInfections and infestations0/551/550/57
Perineal abscessInfections and infestations0/551/550/57
PneumoniaInfections and infestations1/550/550/57
Atrioventricular block completeCardiac disorders1/550/550/57
Cardiac failure congestiveCardiac disorders1/550/550/57
Coronary artery diseaseCardiac disorders1/550/550/57
Left ventricular failureCardiac disorders1/550/550/57
Most frequent other events
Showing 10 of 52
Most frequent other events
EventRazuprotafib 15mg Twice DailyRazuprotafib 15mg DailyPlacebo Twice Daily
Diabetic retinal oedemaEye disorders7/558/557/57
NasopharyngitisInfections and infestations5/554/558/57
Urinary tract infectionInfections and infestations7/554/552/57
Retinal neovascularisationEye disorders2/554/557/57
InfluenzaInfections and infestations3/555/554/57
Upper respiratory tract infectionInfections and infestations1/551/555/57
BronchitisInfections and infestations4/552/550/57
Vitreous floatersEye disorders2/552/554/57
Dry eyeEye disorders1/552/554/57
SinusitisInfections and infestations2/553/553/57

Baseline characteristics

Age, Continuous
Age, Continuous(years)Razuprotafib 15mg Twice DailyRazuprotafib 15mg DailyPlacebo Twice DailyTotal
Mean56.7 ± 11.1758.5 ± 10.6955.9 ± 9.8857.0 ± 10.58
Sex: Female, Male
Sex: Female, Male(Participants)Razuprotafib 15mg Twice DailyRazuprotafib 15mg DailyPlacebo Twice DailyTotal
Female23232571
Male32323296
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Razuprotafib 15mg Twice DailyRazuprotafib 15mg DailyPlacebo Twice DailyTotal
Hispanic or Latino25202570
Not Hispanic or Latino30353297
Unknown or Not Reported0000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Razuprotafib 15mg Twice DailyRazuprotafib 15mg DailyPlacebo Twice DailyTotal
American Indian/Native Alaskan1023
Asian2316
Black/African American47314
Native Hawaiian/Pacific Islander0011
White474549141
Other1012
Body Mass Index, kg/m²
Body Mass Index, kg/m²(kg/m²)Razuprotafib 15mg Twice DailyRazuprotafib 15mg DailyPlacebo Twice DailyTotal
Mean31.91 ± 4.77629.63 ± 5.13830.58 ± 4.75230.71 ± 4.949
Hemoglobin A1c, %
Hemoglobin A1c, %(% of Glycated hemoglobin)Razuprotafib 15mg Twice DailyRazuprotafib 15mg DailyPlacebo Twice DailyTotal
Mean8.58 ± 1.3808.31 ± 1.8858.18 ± 1.4578.35 ± 1.587
Type of Diabetes, n (%)
Type of Diabetes, n (%)(Participants)Razuprotafib 15mg Twice DailyRazuprotafib 15mg DailyPlacebo Twice DailyTotal
Type 166416
Type 2494953151
Duration of Diabetes, years
Duration of Diabetes, years(years)Razuprotafib 15mg Twice DailyRazuprotafib 15mg DailyPlacebo Twice DailyTotal
Mean17.83 ± 12.23217.78 ± 11.00114.54 ± 8.62516.69 ± 10.749

9 further baseline measures are reported on the registry.

08

Study locations

53 sites
  • Arizona Retina and Vitreous Consultants
    Phoenix, Arizona 85021, United States
  • Retinal Research Institute
    Phoenix, Arizona 85053, United States
  • Retina Institute of California
    Arcadia, California 91007, United States
  • California Retina Consultants
    Bakersfield, California 93309, United States
  • Retina Vitreous Associates Medical Group
    Beverly Hills, California 90211, United States
  • Retina Consultants of Orange County
    Fullerton, California 92835, United States
  • Ophthalmic Clinical Trials San Diego
    Oceanside, California 92056, United States
  • Stanford
    Palo Alto, California 94303, United States
  • California Retina Consultants
    Santa Barbara, California 93103, United States
  • California Retina Consultants
    Santa Maria, California 93454, United States
  • Retina Consultants of Southern Colorado
    Colorado Springs, Colorado 80909, United States
  • Colorado Retina Associates
    Golden, Colorado 80401, United States
  • Rand Eye Institute
    Deerfield Beach, Florida 33064, United States
  • Center for Retina and Macular Disease
    Lakeland, Florida 33805, United States
  • Retina Specialty Institute
    Pensacola, Florida 32503, United States
  • Southeast Retina Center
    Augusta, Georgia 30909, United States
  • Georgia Retina
    Marietta, Georgia 30060, United States
  • University Retina
    Oak Forest, Illinois 60452, United States
  • Illinois Retina Associates
    Oak Park, Illinois 60304, United States
  • Midwest Eye Institute
    Indianapolis, Indiana 46290, United States
  • Wolfe Eye Clinic
    West Des Moines, Iowa 50266, United States
  • Central Plains Eye MDs
    Wichita, Kansas 67226, United States
  • Retina Associates of Kentucky
    Lexington, Kentucky 40509, United States
  • Johns Hopkins University School of Medicine
    Baltimore, Maryland 212876, United States
  • Cumberland Valley Retina Consultants PC
    Hagerstown, Maryland 21740, United States
  • Opthalmic Consultants of Boston
    Boston, Massachusetts 02114, United States
  • Specialty Eye Institute
    Jackson, Michigan 49202, United States
  • Sierra Eye Associates
    Reno, Nevada 89502, United States
  • Retina Center of New Jersey
    Bloomfield, New Jersey 07003, United States
  • New Jersey Retina
    Edison, New Jersey 08820, United States
  • Retinal and Ophthalmic Consultants P.C.
    Northfield, New Jersey 08225, United States
  • Eye Associates of New Mexico
    Albuquerque, New Mexico 87109, United States
  • Island Retina
    Shirley, New York 11967, United States
  • Retina Vitreous Surgeons of Central New York
    Syracuse, New York 13224, United States
  • Retina Associates of Cleveland
    Beachwood, Ohio 44122, United States
  • Cincinnati Eye Institute
    Cincinnati, Ohio 45242, United States
  • Retina Associates of Cleveland
    Middleburg Heights, Ohio 44130, United States
  • Retina Associates of Cleveland
    Youngstown, Ohio 44505, United States
  • Retina Vitreous Center
    Edmond, Oklahoma 73013, United States
  • Mid-Atlantic Retina
    Bethlehem, Pennsylvania 18017, United States
  • Tennessee Retina
    Nashville, Tennessee 37203, United States
  • Retina Research Institute of Texas
    Abilene, Texas 79606, United States
  • Texas Retina Associates
    Arlington, Texas 76012, United States
  • Austin Retina Associates
    Austin, Texas 78705, United States
  • Retina Research Center
    Austin, Texas 78705, United States
  • Texas Retina Associates
    Fort Worth, Texas 76104, United States
  • Valley Retina Institute
    Harlingen, Texas 78550, United States
  • Retina and Vitreous of Texas
    Houston, Texas 77025, United States
  • Retina Consultants of Houston
    Houston, Texas 77030, United States
  • Valley Retina Institute
    McAllen, Texas 78503, United States
  • Medical Center Ophthalmology Associates
    San Antonio, Texas 78240, United States
  • Retina Consultants of Houston
    The Woodlands, Texas 77384, United States
  • Spokane Eye Clinical Research
    Spokane, Washington 99204, United States
09

References and documents

Study documents

  • Study protocol · Sep 18, 2017
  • Statistical analysis plan · Feb 27, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03197870
Lead sponsor
EyePoint Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Jun 23, 2017
Start date
Jun 9, 2017
Primary completion
Jan 9, 2019
Completion
Feb 9, 2019
Results posted
Jun 27, 2023
Last update
Jun 27, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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