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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
77
EYP-1901 will be administered to the study eye by a single injection through the pars plana using a pre-loaded applicator with a 22-gauge needle. Each EYP-1901 IVT insert has been designed to deliver vorolanib into the vitreous humor for approximately 6 to 9 months.
Sham injections will be used to maintain masking of investigational EYP-1901 therapy for study subjects.
Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at 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.
Time frame: Baseline (Day 1) and Week 36
Percentage of Subjects Improved >=2 Steps From Baseline in the DRSS Score at 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.
Time frame: Baseline (Day 1), Week 24, and Week 48
Percentage of Subjects Improved >=2 Steps and >=3 Steps From Baseline in DRSS Score at 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.
Time frame: Baseline (Day 1) and Weeks 24, 36 and 48
Percentage of Subjects Worsened >=2 Steps and >=3 Steps From Baseline in DRSS Score at 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
EyePoint Investigative Site
Phoenix, Arizona, United States
EyePoint Investigative Site
Huntington Beach, California, United States
EyePoint Investigative Site
Oxnard, California, United States
EyePoint Investigative Site
Palm Desert, California, United States
EyePoint Investigative Site
Pasadena, California, United States
EyePoint Investigative Site
Poway, California, United States
EyePoint Investigative Site
Sacramento, California, United States
EyePoint Investigative Site
Danbury, Connecticut, United States
EyePoint Investigative Site
Clearwater, Florida, United States
EyePoint Investigative Site
Melbourne, Florida, United States
...and 26 more locations
Time frame: Baseline (Day 1) and Weeks 24, 36 and 48
Percentage of Subjects Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at 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).
Time frame: Weeks 24, 36 and 48
Percentage of Subjects Who Developed Center Involved-Diabetic Macular Edema (CI-DME) at 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 frame: Weeks 24, 36 and 48
Time to Develop Any Neovascular Vision Threatening Complication (PDR/ASNV) at 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 frame: Weeks 24, 36 and 48
Time to Develop CI-DME Through 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.
Time frame: Weeks 24, 36 and 48
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
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.
Time frame: Weeks 24, 36 and 48
Percentage of Subjects Who Received PRP at 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.
Time frame: Weeks 24, 36 and 48
Area Under the Curve (AUC) for Change From Baseline in BCVA at 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.
Time frame: Weeks 24, 36 and 48
Plasma Concentration of EYP-1901 and X-297 at 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.
Time frame: Weeks 24, 36 and 48
Number of Subjects With Ocular and Non-Ocular TEAEs and Serious TEAEs up to Week 48
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.
Time frame: TEAEs were collected from the study drug administration (Day 1) up to end of the study, approximately 48 weeks.