Nonproliferative Diabetic RetinopathyPhase 2TIME-2bNCT03197870
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 study testing AKB-9778 in people with Nonproliferative Diabetic Retinopathy, run by EyePoint Pharmaceuticals, Inc. at 53 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Nonproliferative Diabetic Retinopathy
- What is being tested?
- AKB-9778
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 167 participants
- Where
- 53 sitesUnited States
- Study dates
- 9 Jun 2017to 9 Feb 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
53 sites in 1 country.
53 sites in 1 country
United States53 sites
Retina Research Institute of Texas
Abilene, Texas, 79606
Eye Associates of New Mexico
Albuquerque, New Mexico, 87109
Retina Institute of California
Arcadia, California, 91007
Texas Retina Associates
Arlington, Texas, 76012
Southeast Retina Center
Augusta, Georgia, 30909
Austin Retina Associates
Austin, Texas, 78705
Retina Research Center
Austin, Texas, 78705
California Retina Consultants
Bakersfield, California, 93309
Johns Hopkins University School of Medicine
Baltimore, Maryland, 212876
Retina Associates of Cleveland
Beachwood, Ohio, 44122
Mid-Atlantic Retina
Bethlehem, Pennsylvania, 18017
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211
Retina Center of New Jersey
Bloomfield, New Jersey, 07003
Opthalmic Consultants of Boston
Boston, Massachusetts, 02114
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
Retina Consultants of Southern Colorado
Colorado Springs, Colorado, 80909
Rand Eye Institute
Deerfield Beach, Florida, 33064
New Jersey Retina
Edison, New Jersey, 08820
Retina Vitreous Center
Edmond, Oklahoma, 73013
Texas Retina Associates
Fort Worth, Texas, 76104
Retina Consultants of Orange County
Fullerton, California, 92835
Colorado Retina Associates
Golden, Colorado, 80401
Cumberland Valley Retina Consultants PC
Hagerstown, Maryland, 21740
Valley Retina Institute
Harlingen, Texas, 78550
Retina and Vitreous of Texas
Houston, Texas, 77025
Retina Consultants of Houston
Houston, Texas, 77030
Midwest Eye Institute
Indianapolis, Indiana, 46290
Specialty Eye Institute
Jackson, Michigan, 49202
Center for Retina and Macular Disease
Lakeland, Florida, 33805
Retina Associates of Kentucky
Lexington, Kentucky, 40509
Georgia Retina
Marietta, Georgia, 30060
Valley Retina Institute
McAllen, Texas, 78503
Retina Associates of Cleveland
Middleburg Heights, Ohio, 44130
Tennessee Retina
Nashville, Tennessee, 37203
Retinal and Ophthalmic Consultants P.C.
Northfield, New Jersey, 08225
University Retina
Oak Forest, Illinois, 60452
Illinois Retina Associates
Oak Park, Illinois, 60304
Ophthalmic Clinical Trials San Diego
Oceanside, California, 92056
Stanford
Palo Alto, California, 94303
Retina Specialty Institute
Pensacola, Florida, 32503
Arizona Retina and Vitreous Consultants
Phoenix, Arizona, 85021
Retinal Research Institute
Phoenix, Arizona, 85053
Sierra Eye Associates
Reno, Nevada, 89502
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
California Retina Consultants
Santa Barbara, California, 93103
California Retina Consultants
Santa Maria, California, 93454
Island Retina
Shirley, New York, 11967
Spokane Eye Clinical Research
Spokane, Washington, 99204
Retina Vitreous Surgeons of Central New York
Syracuse, New York, 13224
Retina Consultants of Houston
The Woodlands, Texas, 77384
Wolfe Eye Clinic
West Des Moines, Iowa, 50266
Central Plains Eye MDs
Wichita, Kansas, 67226
Retina Associates of Cleveland
Youngstown, Ohio, 44505
About this study
Official title: Phase 2 Double-Masked, Placebo-Controlled Study to Assess the Safety and Efficacy of Subcutaneously Administered AKB-9778 (Razuprotafib)15mg Once Daily or 15mg Twice Daily for 12 Months in Patients With Moderate to Severe Non-Proliferative Diabetic Retinopathy
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).
- Conditions
- Nonproliferative Diabetic Retinopathy
- Being tested
- AKB-9778, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AKB-9778Drug
Subcutaneous AKB-9778 15mg
PlaceboDrug
Subcutaneous Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: AKB-9778; Drug: Placebo |
| AKB-9778 15mg Twice Daily | Experimental | AKB-9778 15 mg (BID) Receives: Drug: AKB-9778 |
| Placebo Twice Daily | Placebo comparator | Placebo Group: SC Phosphate-Buffered-Saline (PBS) (BID) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to Week 48
Secondary outcomes (7)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: Treatment Period - 12 months (48 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start9 Jun 2017
- Primary completion9 Jan 2019
- Study completion9 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nonproliferative Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197870
- Sponsor's protocol ID
- AKB-9778-CI-5001
- Acronym
- TIME-2b
- Status last verified
- Jun 2023
- First submitted
- 22 Jun 2017
- Last updated
- 27 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Double-Masked, Placebo-Controlled Study to Assess the Safety and Efficacy of Subcutaneously Administered AKB-9778 (Razuprotafib)15mg Once Daily or 15mg Twice Daily for 12 Months in Patients With Moderate to Severe Non-Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT03197870
- Acronym / sponsor ID
- TIME-2b / AKB-9778-CI-5001
- Conditions
- Nonproliferative Diabetic Retinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 9 Jan 2019 (actual)
- Study completion
- 9 Feb 2019 (actual)
- First posted
- 23 Jun 2017 (actual)
- Results
- Posted 27 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AKB-9778 15mg Daily | Experimental | Drug: AKB-9778, Drug: PlaceboAKB-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 | Drug: AKB-9778AKB-9778 15 mg (BID) |
| Placebo Twice Daily | Placebo comparator | Drug: PlaceboPlacebo Group: SC Phosphate-Buffered-Saline (PBS) (BID) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AKB-9778Subcutaneous AKB-9778 15mg | Drug | AKB-9778 15mg Daily, AKB-9778 15mg Twice Daily |
| PlaceboSubcutaneous Placebo | Drug | AKB-9778 15mg Daily, Placebo Twice Daily |
Primary outcome
Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps
Time frame: Baseline to Week 48
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
7 secondary outcomes
Summary of Subjects With a Worsening in the Study Eye DRSS of ≥ 2 Steps at Week 48
Time frame: Baseline to Week 48
Mean Change From Baseline in DRSS in the Study Eye at Week 48
Time frame: Week 48
Summary of Subjects With an Improvement or Worsening in the Study Eye DRSS of ≥ 3 Steps at Week 48.
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 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
Time frame: Treatment Period - 12 months (48 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
53 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AKB-9778 in people with Nonproliferative Diabetic Retinopathy, run by EyePoint Pharmaceuticals, Inc. at 53 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps (time frame: Baseline to Week 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.