Phase 2
Completed N=167
The TIME-2b Study: A Study of AKB-9778 (Razuprotafib), a Novel Tie 2 Activator, in Patients With Non-Proliferative Diabetic Retinopathy (NPDR)
Nonproliferative Diabetic Retinopathy
Source: ClinicalTrials.gov NCT03197870 ↗
Enrolled (actual)
167
Serious AEs
11.4%
Results posted
Jun 2023
Primary outcomePrimary: Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps — 0; 5; 2 eyes — p=0.495
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With an Improvement in Study Eye Severity of Diabetic Retinopathy (DR) (ETDRS DR Severity Score or DRSS) of ≥ 2 Steps |
0; 5; 2 | 0.495 |
| SECONDARY Summary of Subjects With a Worsening in the Study Eye DRSS of ≥ 2 Steps at Week 48 |
5; 6; 4 | — |
| SECONDARY Mean Change From Baseline in DRSS in the Study Eye at Week 48 |
5.0; 4.9; 4.8 | — |
| SECONDARY Summary of Subjects With an Improvement or Worsening in the Study Eye DRSS of ≥ 3 Steps at Week 48. |
3; 4; 3; 0; 0; 0 | — |
| 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) |
0; 5; 1 | — |
| 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) |
0; 5; 1 | — |
| SECONDARY Summary of Patients Developing Center-involved DME or PDR or PDR-related Outcomes During Treatment Period Based on Clinical Data. |
12; 10; 10 | — |
| 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 |
10; 8; 7 | — |
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
Data sourced from ClinicalTrials.gov (NCT03197870). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.