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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AKB-9778 15mg Daily | Experimental | 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 |
|
| AKB-9778 15mg Twice Daily | Experimental | AKB-9778 15 mg (BID) |
|
| Placebo Twice Daily | Placebo Comparator | Placebo Group: SC Phosphate-Buffered-Saline (PBS) (BID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AKB-9778 | Drug | Subcutaneous AKB-9778 15mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Retina and Vitreous Consultants | Phoenix | Arizona | 85021 | United States | ||
| Retinal Research Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | Razuprotafib 15mg Twice Daily | Razuprotafib: Subcutaneous Razuprotafib 15mg |
| FG001 | Razuprotafib 15mg Daily | Razuprotafib: Subcutaneous Razuprotafib 15mg Placebo: Subcutaneous Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 18, 2017 | Jan 18, 2023 |
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| Placebo |
| Drug |
Subcutaneous Placebo |
|
| Baseline to Week 48 |
| 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 | Week 48 |
| 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 | Baseline to Week 48 |
| 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 | Treatment Period - 12 months (48 weeks) |
| 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 | Treatment Period - 12 months (48 weeks) |
| 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. | Treatment Period - 12 months (48 weeks) |
| 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 | Treatment Period - 12 months (48 weeks) |
| 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 |
| FG002 | Placebo Twice Daily | Placebo: Subcutaneous Placebo |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Razuprotafib 15mg Twice Daily | Razuprotafib: Subcutaneous Razuprotafib 15mg |
| BG001 | Razuprotafib 15mg Daily | Razuprotafib: Subcutaneous Razuprotafib 15mg Placebo: Subcutaneous Placebo |
| BG002 | Placebo Twice Daily | Placebo: Subcutaneous Placebo |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| |||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||
| Body Mass Index, kg/m² | Mean | Standard Deviation | kg/m² |
| ||||||||||
| Hemoglobin A1c, % | Mean | Standard Deviation | % of Glycated hemoglobin |
| ||||||||||
| Type of Diabetes, n (%) | Count of Participants | Participants |
| |||||||||||
| Duration of Diabetes, years | Mean | Standard Deviation | years |
| ||||||||||
| Taking Insulin, n (%) | Count of Participants | Participants |
| |||||||||||
| Taking Angiotensin-Converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) | Count of Participants | Participants |
| |||||||||||
| Study eye, n (%) | Count of Participants | Participants |
| |||||||||||
| Duration of non-proliferative diabetic retinopathy in Study Eye, years | The "n" for this Baseline Characteristic does not match the overall population. The overall number of participants analyzed represents the total number of participants in each treatment group for the safety population. The summary included only those participants with available data. | Mean | Standard Deviation | years |
| |||||||||
| Duration of NPDR in qualified fellow eye, years | If both eyes met all ocular eligibility criteria, then the eye with the worse ETDRS DRSS was designated the study eye, and the other eye designated as a qualified fellow eye; in this case, the Central Image Reading Center confirmed selection of the study eye. Not all subjects had a qualified fellow eye with NPDR (Non-Proliferative Diabetic Retinopathy). | Qualified fellow eyes only | Mean | Standard Deviation | years |
| ||||||||
| Prior Treatment for Proliferative Diabetic Retinopathy or Diabetic Macular Edema in Study Eye | Count of Participants | Participants |
| |||||||||||
| Prior Treatment for PDR or DME in Qualified Fellow Eye | If both eyes met all ocular eligibility criteria, then the eye with the worse ETDRS DRSS was designated the study eye, and the other eye designated as a qualified fellow eye; in this case, the Central Image Reading Center confirmed selection of the study eye. Not all subjects had a qualified fellow eye with prior treatment for PDR (Proliferative Diabetic Retinopathy). | Count of Participants | Participants |
| ||||||||||
| Diabetic Retinopathy Severity Scale Score in Study Eye | 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 | Mean | Standard Deviation | units on a scale |
| |||||||||
| Best-Corrected Visual Acuity in Study Eye, Letters | Mean | Standard Deviation | letter score |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The modified intent-to-treat population consisted of all enrolled subjects who received at least 1 dose of study medication and was the population used for the efficacy population. | Posted | Count of Units | eyes | Baseline to Week 48 | eyes | eyes |
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| Secondary | 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 | The modified intent-to-treat population consisted of all enrolled subjects who received at least 1 dose of study medication and was the population used for the efficacy population. | Posted | Count of Units | study eyes | Baseline to Week 48 | study eyes | study eyes |
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| Secondary | 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 | Modified Intent-to-Treat Population With at Least 1 Scheduled Post-Baseline Measure (LOCF) | Posted | Mean | Standard Deviation | score on a scale | Week 48 |
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| Secondary | 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 | The modified intent-to-treat population consisted of all enrolled subjects who received at least 1 dose of study medication and was the population used for the efficacy population. | Posted | Count of Units | study eyes | Baseline to Week 48 | study eyes | study eyes |
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| Secondary | 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 | Modified Intent-to-Treat Population with at least 1 scheduled Post-Baseline Measure (LOCF) | Posted | Count of Participants | Participants | Treatment Period - 12 months (48 weeks) |
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| Secondary | 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 | Modified Intent-to-Treat Population with at least 1 scheduled Post-Baseline Measure (LOCF) | Posted | Count of Participants | Participants | Treatment Period - 12 months (48 weeks) |
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| Secondary | 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. | mITT Population With ≥1 Scheduled Post-Baseline Measure (LOCF) | Posted | Count of Units | study eyes | Treatment Period - 12 months (48 weeks) | study eyes | study eyes |
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| Secondary | 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 | Modified Intent-to-Treat Population With at Least 1 Scheduled Post-Baseline Measure (LOCF) | Posted | Count of Participants | Participants | Treatment Period - 12 months (48 weeks) |
|
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)]
Not provided
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Razuprotafib 15mg Twice Daily | Razuprotafib: Subcutaneous Razuprotafib 15mg | 0 | 55 | 8 | 55 | 55 | 55 |
| EG001 | Razuprotafib 15mg Daily | Razuprotafib: Subcutaneous Razuprotafib 15mg Placebo: Subcutaneous Placebo | 0 | 55 | 6 | 55 | 55 | 55 |
| EG002 | Placebo Twice Daily | Placebo: Subcutaneous Placebo | 1 | 57 | 5 | 57 | 57 | 57 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteomyelitis | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Burn infection | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Diabetic gangrene | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Perineal abscess | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Left ventricular failure | Cardiac disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Mallory-Weiss syndrome | Gastrointestinal disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Oesophageal stenosis | Gastrointestinal disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Orthostatic hypotension | Vascular disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA version 20.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MeDRA version 20.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Localized infection | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Herpes Zoster | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Diabetic retinal oedema | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Retinal neovascularisation | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Eye pain | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Visual impairment | Infections and infestations | MeDRA version 20.1 | Systematic Assessment |
| |
| Cataract nuclear | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Glaucoma | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Macular fibrosis | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Vitreous floaters | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Cataract cortical | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Cataract subcapsular | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Diplopia | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Eye irritation | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Eye pruritis | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Iris adhesions | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Macular oedema | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Presbyopia | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Pterygium | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Pupillary reflex impaired | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Retinal cyst | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Retinal exudate | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Retinal haemorrhage | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Vitreous detachment | Eye disorders | MeDRA version 20.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MeDRA version 20.1 | Systematic Assessment |
| |
| Foreign body in eye | Injury, poisoning and procedural complications | MeDRA version 20.1 | Systematic Assessment |
| |
| Hyphaema | Injury, poisoning and procedural complications | MeDRA version 20.1 | Systematic Assessment |
|
Principal Investigators are not employed by the organization sponsoring the study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Bauer | EyePoint Pharmaceuticals, Inc | 8573410747 | dbauer@eyepointpharma.com |
| Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 27, 2019 | Jan 18, 2023 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| C000598564 | AKB-9778 |
Not provided
Not provided
Not provided
|
|
|
|
| Asian |
|
|
| Black/African American |
|
|
| Native Hawaiian/Pacific Islander |
|
|
| White |
|
|
| Other |
|
|
|
|
|
| Type 2 |
|
|
|
|
| No |
|
|
|
| No |
|
|
|
| Left Eye |
|
|
|
|
|
| No |
|
|
|
| No |
|
|
|
|
| OG002 |
| Placebo Twice Daily |
Placebo Group: SC Phosphate-Buffered-Saline (PBS) (BID) Placebo: Subcutaneous Placebo |
|
|
| Placebo Twice Daily |
Placebo Group: SC Phosphate-Buffered-Saline (PBS) (BID) Placebo: Subcutaneous Placebo |
|
|
| OG002 | Placebo Twice Daily | Placebo Group: SC Phosphate-Buffered-Saline (PBS) (BID) Placebo: Subcutaneous Placebo |
|
|
AKB-9778 15 mg (BID) AKB-9778: Subcutaneous AKB-9778 15mg |
| OG002 | Placebo Twice Daily | Placebo Group: SC Phosphate-Buffered-Saline (PBS) (BID) Placebo: Subcutaneous Placebo |
|
|
AKB-9778 15 mg (BID) AKB-9778: Subcutaneous AKB-9778 15mg |
| OG002 | Placebo Twice Daily | Placebo Group: SC Phosphate-Buffered-Saline (PBS) (BID) Placebo: Subcutaneous Placebo |
|
|
| Units | Counts |
|---|---|
| Participants |
|
| study eyes |
|
|
| OG002 | Placebo Twice Daily | Placebo Group: SC Phosphate-Buffered-Saline (PBS) (BID) Placebo: Subcutaneous Placebo |
|
|