Study of EYP-1901 in Patients With Nonproliferative Diabetic Retinopathy (NPDR)
- Conditions
- Nonproliferative Diabetic Retinopathy
- Interventions
- Other: Sham IVT
- Registration Number
- NCT05383209
- Lead Sponsor
- EyePoint Pharmaceuticals, Inc.
- Brief Summary
A prospective, randomized, double-masked study that evaluated the ocular efficacy and safety of two doses of the EYP-1901 intravitreal (IVT) insert compared to sham.
- Detailed Description
This study evaluated the ocular efficacy and safety of two doses of the EYP-1901 IVT insert compared to sham using a randomized double-masked trial design.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 77
- Participants must have a hemoglobin A1c <=12%
- Study eye with moderately severe to severe Non proliferative Diabetic Retinopathy (NPDR) (based on the Diabetic Retinopathy Severity Scale (DRSS) levels 47 or 53)
- Best corrected visual acuity (BCVA) using Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of >=69 letters (approximate Snellen equivalent of 20/40 or better).
- Presence of any active Center involved-diabetic macular edema in the study eye as determined by the Investigator on clinical examination, or within the central subfield thickness (CST) of the study eye, with a CST threshold greater than 320 microns.
- Any evidence or documented history of prior focal or grid laser photocoagulation or any pan-retinal photocoagulation (PRP) in the study eye in the last 12 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EYP-1901 2060 ug EYP-1901 EYP-1901 2060 ug; single injection EYP-1901 3090 ug EYP-1901 EYP-1901 3090 ug; single injection Sham IVT Sham IVT Sham IVT; single injection
- Primary Outcome Measures
Name Time Method Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 36 Baseline (Day 1) and Week 36 The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced proliferative diabetic retinopathy (PDR): posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at Week 36 from baseline.
- Secondary Outcome Measures
Name Time Method Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at Week 24 and Week 48 Baseline (Day 1), Week 24, and Week 48 The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced proliferative diabetic retinopathy (PDR): posterior fundus obscured, or center of macula detached). Here, DRSS describes severity levels 47 (moderately severe NPDR) and 53 (severe NPDR) at Weeks 24 and 48 from baseline.
Percentage of Subjects Improved >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48 Baseline (Day 1) and Weeks 24, 36 and 48 The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced PDR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at Weeks 24, 36 and 48 from baseline.
Percentage of Subjects Worsened >=2 Steps and >=3 Steps From Baseline in DRSS Score at Weeks 24, 36 and 48 Baseline (Day 1) and Weeks 24, 36 and 48 The DRSS used to describe overall retinopathy severity as well as the change in severity over time in the study eye. Severity ranges from level 10 (diabetic retinopathy absent) to level 85 (advanced PDR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at Weeks 24, 36 and 48 from baseline.
Percentage of Subjects Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Weeks 24, 36 and 48 Weeks 24, 36 and 48 The vision threatening complications in the study eye due to diabetic retinopathy were indicated by the presence of "Vitreous hemorrhage" or the presence of "Tractional retinal detachment" reported on the Ocular Examination - Dilated Ophthalmoscopy CRF (PDR events), and "Neovascularization for the Iris" answered as "Yes" or "Neovascularization for the Angle" answered as "Yes" per the Ocular Examination - Slit Lamp Biomicroscopy CRF (anterior segment neovascularization (ASNV) events).
Percentage of Subjects Who Developed Center Involved-Diabetic Macular Edema (CI-DME) at Weeks 24, 36 and 48 Weeks 24, 36 and 48 The CI-DME in the study eye occurred when a treatment emergent adverse event (TEAE) with a mapped preferred term of 'Cystoid macular oedema', 'Diabetic retinal oedema', or 'Macular oedema' occurred in the study eye, in combination with the temporally closest centrally read custom algorithm CST measurement being greater than or equal to 320 microns.
Time to Develop Any Neovascular Vision Threatening Complication (PDR/ASNV) at Weeks 24, 36 and 48 Weeks 24, 36 and 48 Time to develop any PDR/ASNV was computed as the date of the first development of PDR/ASNV in the study eye minus the date of study treatment administration plus 1 day, divided by 7 days per week.
Time to Develop CI-DME Through Weeks 24, 36 and 48 Weeks 24, 36 and 48 The occurrence of a CI-DME event in the study eye was identified via examination of centrally read custom algorithm CST data and adverse events.
Percentage of Subjects Who Received Anti-Vascular Endothelial Growth Factor (VEGF) or Additional Standard of Care Intervention Due to Ocular Diabetic Complications at Weeks 24, 36 and 48 Weeks 24, 36 and 48 Percentage of subjects who received anti-VEGF or additional standard of care intervention due to ocular diabetic complications in the study eye are reported. Anti-VEGF use was identified in reported concomitant medication data.
Percentage of Subjects Who Received PRP at Weeks 24, 36 and 48 Weeks 24, 36 and 48 Percentage of subjects who received PRP in the study eye, inclusive of subjects undergoing vitrectomy with endo-laser are reported.
Area Under the Curve (AUC) for Change From Baseline in BCVA at Weeks 24, 36 and 48 Weeks 24, 36 and 48 The AUC for change from baseline in BCVA in the study eye were summarized. The AUC through each time point of interest was computed using the trapezoidal rule normalized to months, with a final unit of letters.
Plasma Concentration of EYP-1901 and X-297 at Weeks 24, 36 and 48 Weeks 24, 36 and 48 Blood samples were collected at the specific visits for the Pharmacokinetic (PK) analysis of EYP-1901 and its main metabolite concentrations.
Number of Subjects With Ocular and Non-Ocular TEAEs and Serious TEAEs up to Week 48 TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks. An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a patient or clinical investigation subject administered an investigational or marketed (medicinal) product and that does not necessarily have a causal relationship with the product. A serious AE is any AE that results in one of the following outcomes: death; life-threatening; requires in-patient hospitalization; results in a persistent or significant disability/incapacity; congenital anomaly/birth defect; other important medical event. The TEAEs are AEs that occur after the first dose of study treatment administration.
Trial Locations
- Locations (1)
EyePoint Investigative Site
🇺🇸Bellevue, Washington, United States
EyePoint Investigative Site🇺🇸Bellevue, Washington, United States