Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05802329
Other study ID # OCU200-101
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date April 2023
Est. completion date September 2023

Study information

Verified date March 2023
Source Ocugen
Contact Shane Spence
Phone 484-237-3384
Email shane.spence@ocugen.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A Phase 1 study to assess the safety and efficacy of OCU200 for center-involved diabetic macular edema


Description:

This is a multicenter, open-label, dose ranging study with 3 cohorts in the dose-escalation portion of the study and 1 cohort in the combination therapy portion of the study. An accelerated 3+3 design with parallel and sequential dosing will be used. A total of 9 to 22 participants will be enrolled in the dose-escalation portion of the study to receive OCU200 alone (9 to 18 participants enrolled according to the 3+3 design and up to 4 participants replaced due to parallel cohort initiation). For the combination therapy cohort, a total of 3 to 6 participants will be enrolled to receive OCU200 (MTD) + Lucentis. A total of up to 28 participants will be included in this study. The following algorithm will be followed for dose-escalation: Cohort 1 Low Dose (0.5 mg/mL): 3+3 participants will receive intravitreal injection of OCU200 low dose concentration. 1 of 3 results will occur from the first 3 Cohort 3 participants (first dose): 1. If none of the first 3 participants on high dose concentration are determined by the DSMB to have a DLT, then the high dose concentration will be the determined MTD. 2. If 2 or more of the first 3 participants on the high dose concentration are determined by the DSMB to have a DLT, then the medium dose concentration (1 mg/mL) will be the determined MTD. Any dosing on Cohort 4 will be paused and continuation will be re-assessed. 3. If exactly 1 of the first 3 participants on high dose concentration is determined by the DSMB to have a DLT, then 3 additional participants will be enrolled on high dose concentration. Any dosing on Cohort 4 will be paused and continuation will be reassessed. 1. If none of the 3 additional participants are determined by the DSMB to have a DLT, then the high dose concentration will be the determined MTD. 2. If 1 or more of the 3 additional participants are determined by the DSMB to have a DLT, then the medium dose concentration will be the determined MTD. Upon positive DSMB recommendation following dose 1, participants will subsequently receive a 2nd dose (6 weeks later) according to their assigned cohort. The DSMB will review 2 weeks of safety data post 2nd dosing. If a DLT occurs after the 2nd dose of any subject, the dosing interval or dose concentration will be re-assessed. The following algorithm will be followed for combination therapy cohort: Cohort 4 MTD + Lucentis: 3 + 3 additional participants will be enrolled to receive OCU200 (High Dose or MTD) + Lucentis (in a sequential manner on dosing dates). The sentinel participant in Cohort 4 will only be dosed after DSMB review of safety data for the sentinel subject in Cohort 3 or the determination of OCU200 MTD. If the sentinel participant does not have a DLT as determined by DSMB, two additional participants will be dosed. The DSMB will continue to review all available safety data two weeks post dosing of participants. Cohort 2 Medium Dose (1 mg/mL): 3+3 participants will receive intravitreal injection of OCU200 medium dose concentration. Following the same algorithm as Cohort 1. Cohort 3 High Dose (2 mg/mL): 3+3 participants will receive intravitreal injection of OCU200 high dose concentration. Following the same algorithm as Cohort 2.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 28
Est. completion date September 2023
Est. primary completion date September 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Diagnosis of Type 1 or Type 2 Diabetes Mellitus 2. Decreased visual acuity attributable primarily to DME 3. Central-involved DME with central retinal subfield thickness (CST) values, as assessed with spectral-domain optical coherence tomography (SD-OCT) of: 1. = 320 if male or = 305 µm if female on Heidelberg Spectralis 2. = 305 if male or = 290 if female on Zeiss Cirrus 3. BCVA = 78 and = 24 letters on ETDRS chart (approximately 20/32 to 20/320 Snellen equivalents, respectively) in the study eye. 4. Sufficient ocular media clarity, pupillary dilation and participant cooperation to permit acquisition of good quality retinal imaging 5. No history of prior anti-VEGF injection for treatment of DME or history of at least 2 consecutive anti-VEGF intravitreal injection (less than 7 weeks apart) for the treatment of DME with documented incomplete resolution of central subfield thickening within 1 year prior to the screening visit. The last injection should be within 3 months prior to the screening visit. Exclusion Criteria: 1. Presence of any condition that prevent clear visualization of retina (e.g., significant cataract, vitreous hemorrhage) 2. Uncontrolled hypertension (systolic pressure above 180 mmHg or diastolic pressure above 110 mmHg) 3. Uncontrolled glaucoma 4. Concurrent disease in the study eye, other than central-involved DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results 5. Intravitreal or periocular steroid treatment within 3 months prior to the screening visit or fluocinolone acetonide implant (Iluvien®) within 36 months prior to screening visit or dexamethasone implant (Ozurdex®) within 6 months prior to the screening visit. 6. Any ocular surgery within 3 months prior to the screening visit in the study eye (e.g., cataract surgery, corneal refractive surgery) 7. Prior vitrectomy in the study eye 8. Uncontrolled/poorly controlled diabetes, as defined by Glycated hemoglobin (HbA1c) = 12% 9. History of retinal detachment in the study eye 10. History of any other retinal vascular disease in the study eye including conditions that affect macular perfusion (e.g., retinal artery occlusion, retinal vein occlusion, vasculitis) 11. Focal or pan-retinal laser photocoagulation in the study eye within 3 months prior to the screening visit 12. Presence of any inherited retinal disease (e.g., chorioretinal dystrophies, rod/cone dystrophies)Any proliferative diabetic retinopathy

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
OCU200 Low Dose
Intravitreal Injection
OCU200 Medium Dose
Intravitreal Injection
OCU200 High Dose
Intravitreal Injection

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ocugen

Outcome

Type Measure Description Time frame Safety issue
Other Improvement of diabetic retinopathy severity scale (DRSS) Proportion of participants with = 2-step improvement of diabetic retinopathy severity scale (DRSS) 20 weeks
Other Change from baseline in BCVA letters. Dose response as assessed by mean change from baseline in BCVA letters using ETDRS chart and mean number of injections by study visit 20 weeks
Other Changes in CST. Changes from baseline in CST on SD-OCT exam 20 weeks
Other Best Corrected Visual Acuity Changes from baseline in BCVA measured by ETDRS chart 20 Weeks
Other Reduction of CST The proportion of participants having a = 10% reduction of CST at Week 13 and Week 19 20 Weeks
Other mean increase = 5 BCVA letters The proportion of participants having a mean increase = 5 BCVA letters at Week 13 and Week 19 20 Weeks
Other Requirement of rescue intervention The proportion of participants who require rescue intervention 20 weeks
Primary Study Drug-related adverse events (SDAE) Counts, frequencies and percentages of SDAEs. 20 weeks
Primary treatment-emergent adverse events (TEAEs) Counts, frequencies and percentages TEAEs. TEAEs are defined as an event that was not present prior to administration of the dose of study drug and present after the dose, or if it represents the exacerbation of an event that was present prior to the dose. 20 weeks
Primary serious adverse events (SAEs) Counts, frequencies and percentages of SAEs including Resulted in Death, Life-threatening, Hospitalization, Disabling/incapacitating, Congenital anomaly or birth defect and Medically significant AEs ( AE that did not meet any of the above criteria but could have jeopardized the subject and might have required medical or surgical intervention to prevent one of the outcomes listed above). 20 weeks
Secondary Best-corrected visual acuity (BCVA) Measured as the ETDRS letter score on the EVA tester or E-ETDRS charts. 20 Weeks (Changes from baseline)
Secondary Intraocular pressure (IOP) IOP measurement by applanation or rebound tonometry. Confirmation with Goldmann tonometer if IOP reading is outside the normal range (8-21mmHg). 20 weeks(Changes from baseline)
Secondary Slit-lamp biomicroscopy Changes in visual function. 20 Weeks(Changes from baseline)
Secondary Indirect ophthalmoscopy If visual acuity is so poor that the participant is unable to count fingers or perceive hand motion, light perception will be tested with the indirect ophthalmoscope as the light source. 20 Weeks (Changes from baseline)
Secondary Color fundus photography Color fundus photographs will be taken to evaluate retinal anatomy and grade diabetic retinopathy severity scale (DRSS). 20 Weeks(Changes from baseline)
Secondary Spectral Domain Optical Coherence Tomography (SD-OCT) SD-OCT will be utilized to assess retinal thickness. OCT images and scans will be transmitted to a central reading center for independent analysis. 20 Weeks(Changes from baseline)
Secondary Spectral Domain Optical Coherence Tomography Angiography (SD-OCTA) SD-OCTA will be utilized to assess retinal vasculature and images will be transmitted to a central reader for independent analysis. 20 weeks (Changes from baseline)
Secondary Wide-field Fluorescein Angiography (wf-FA) wf-FA will be conducted at screening and EOS visits to assess central and peripheral vasculature. 20 weeks (Changes from baseline)
Secondary Anti-OCU200 antibody formation Blood samples will be collected for the assessment. 20 weeks
Secondary OCU200 Pharmacokinetics parameters Blood samples will be collected for the assessment. 20 weeks
See also
  Status Clinical Trial Phase
Completed NCT03953807 - A Study to Evaluate the Effectiveness and Safety of OZURDEX® in Patients With Diabetic Macular Edema But Never Treated Phase 4
Completed NCT03622580 - A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (YOSEMITE) Phase 3
Recruiting NCT06262737 - Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
Terminated NCT04611152 - A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
Terminated NCT04603937 - A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME) Phase 3
Active, not recruiting NCT04108156 - This Study Will Evaluate the Efficacy, Safety, and Pharmacokinetics of the Port Delivery System With Ranibizumab in Participants With Diabetic Macular Edema Compared With Intravitreal Ranibizumab Phase 3
Completed NCT02867735 - A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema Phase 1
Withdrawn NCT03629210 - Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema Phase 2
Withdrawn NCT02842541 - Safety Study of Intravitreal EBI-031 Given as a Single or Repeat Injection to Subjects With Diabetic Macular Edema Phase 1
Completed NCT02221453 - Cytokine Levels in Patients With Persistent Diabetic Macular Edema Treated With Triamcinolone Acetonide Phase 2
Completed NCT02556723 - Intravitreal Injections of Ziv-aflibercept for Macular Diseases N/A
Completed NCT02979665 - Changes to the Retina Following Anti-VEGF Treatments for Diabetic Macular Edema
Completed NCT02000102 - Outcomes of Diabetic Macula Edema Patients Switched to Aflibercept From Bevacizumab and/or Ranibizumab N/A
Completed NCT02088229 - Relating Retinal Structural and Functional Parameters to Visual Acuity in Eyes Undergoing Treatment for Diabetic Macular Edema N/A
Terminated NCT00779142 - Utility of Intravitreal Methotrexate in Diabetic Macular Edema Resistant to Conventional Therapies N/A
Completed NCT01171976 - Efficacy and Safety of Ranibizumab in Two "Treat and Extend" Treatment Algorithms Versus Ranibizumab As Needed in Patients With Macular Edema and Visual Impairment Secondary to Diabetes Mellitus Phase 3
Completed NCT00989989 - Efficacy and Safety of Ranibizumab (Intravitreal Injections) in Patients With Visual Impairment Due to Diabetic Macular Edema Phase 3
Completed NCT00683176 - Effect of Choline Fenofibrate (SLV348) on Macular Edema Phase 2
Completed NCT01259609 - Changes in Ciliary Body Thickness in Patients With Diabetic Macular Edema After Vitrectomy N/A
Terminated NCT00768040 - Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema Phase 2