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Safety and Tolerability of OCU-10-C-110 for Injection in Subjects With Neovascular Age-related Macular Degeneration

Primary Purpose

Neovascular Age-related Macular Degeneration (nAMD)

Status
Not yet recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
OCU-10-C-110 for Injection
Sponsored by
Ocugenix Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Age-related Macular Degeneration (nAMD) focused on measuring neovascular age-related macular degeneration; intravitreal

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Angiographically documented active choroidal neovascular (CNV) lesion (i.e., leakage on fluorescein angiography or subretinal, intraretinal, or sub-retinal pigment epithelium [sub-RPE] fluid on spectral domain optical coherence tomography [SD-OCT]) secondary to age-related macular degeneration (AMD), within the previous 10 weeks Subjects must have received, 7 to 14 days prior to the Baseline Visit, an intravitreal injection in the study eye of an anti-vascular endothelial growth factor (VEGF) ocular therapeutic approved for use in the United States Exclusion Criteria: History or current evidence of a medical condition (systemic or ophthalmic disease, metabolic dysfunction, physical examination finding or clinical laboratory finding) that may, in the opinion of the investigator, preclude the safe administration of the study medication, adherence to the scheduled study visits, or safe participation in the study or affect the results of the study (e.g., unstable or progressive cardiovascular, cerebral vascular, pulmonary, Parkinson's, liver or renal disease, depression, cancer, or dementia) History or evidence of the following surgeries/procedures in the study eye: Submacular surgery Vitrectomy Retinal detachment or retinal tear Incisional glaucoma surgery

Sites / Locations

  • Strategic Clinical Research Group LLC
  • Retina Research Institute of Texas

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort A - Dose 1

Cohort A - Dose 2

Cohort A - Dose 3

Cohort B - Dose TBD

Arm Description

Outcomes

Primary Outcome Measures

Ocular safety - AE
Number of Adverse events

Secondary Outcome Measures

Systemic safety - AE
Number of Adverse events

Full Information

First Posted
June 6, 2023
Last Updated
September 29, 2023
Sponsor
Ocugenix Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05904691
Brief Title
Safety and Tolerability of OCU-10-C-110 for Injection in Subjects With Neovascular Age-related Macular Degeneration
Official Title
Safety and Tolerability of Single Ascending Doses and Multiple Repeat Doses of OCU-10-C-110 for Injection in Study Participants With Neovascular Age-related Macular Degeneration (nAMD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2025 (Anticipated)
Study Completion Date
May 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ocugenix Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Multi-center, open-label, two-part safety assessment following administration of single ascending doses and repeat administration of the HTD of OCU-10-C-110 for Injection in the study eye of participants with nAMD
Detailed Description
In Part A, subjects will receive a single intravitreal dose in a single eye of the drug product. Dose will be escalated in 3 successive cohorts, pending safety. In Part B, subjects will receive 3 treatments in a single eye of drug product at 4 week intervals of the maximally tolerated dose, with an additional 4 weeks of observation for safety. .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration (nAMD)
Keywords
neovascular age-related macular degeneration; intravitreal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Multi-center, open-label, two-part safety assessment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A - Dose 1
Arm Type
Experimental
Arm Title
Cohort A - Dose 2
Arm Type
Experimental
Arm Title
Cohort A - Dose 3
Arm Type
Experimental
Arm Title
Cohort B - Dose TBD
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
OCU-10-C-110 for Injection
Intervention Description
OCU-10-C-110 for Injection in one of 3 doses
Primary Outcome Measure Information:
Title
Ocular safety - AE
Description
Number of Adverse events
Time Frame
Cohort A - 8 weeks; Cohort B - 12 weeks
Secondary Outcome Measure Information:
Title
Systemic safety - AE
Description
Number of Adverse events
Time Frame
Cohort A - 8 weeks; Cohort B - 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Angiographically documented active choroidal neovascular (CNV) lesion (i.e., leakage on fluorescein angiography or subretinal, intraretinal, or sub-retinal pigment epithelium [sub-RPE] fluid on spectral domain optical coherence tomography [SD-OCT]) secondary to age-related macular degeneration (AMD), within the previous 10 weeks Subjects must have received, 7 to 14 days prior to the Baseline Visit, an intravitreal injection in the study eye of an anti-vascular endothelial growth factor (VEGF) ocular therapeutic approved for use in the United States Exclusion Criteria: History or current evidence of a medical condition (systemic or ophthalmic disease, metabolic dysfunction, physical examination finding or clinical laboratory finding) that may, in the opinion of the investigator, preclude the safe administration of the study medication, adherence to the scheduled study visits, or safe participation in the study or affect the results of the study (e.g., unstable or progressive cardiovascular, cerebral vascular, pulmonary, Parkinson's, liver or renal disease, depression, cancer, or dementia) History or evidence of the following surgeries/procedures in the study eye: Submacular surgery Vitrectomy Retinal detachment or retinal tear Incisional glaucoma surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sean McDonald
Phone
(412) 600-6379
Email
sean@ocugenixtx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roger Goldberg, MD
Organizational Affiliation
Lexitas Pharma
Official's Role
Study Director
Facility Information:
Facility Name
Strategic Clinical Research Group LLC
City
Abilene
State/Province
Texas
ZIP/Postal Code
76087
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley York
Phone
682-703-4318
Email
ashley.york@txscrg.com
First Name & Middle Initial & Last Name & Degree
Lorena Stubblefield
Phone
(682) 703-4320
Email
lorena.stubblefield@txscrg.com
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deisy Villarreal
Phone
325-960-4414
Email
Deisy.villarreal@txicr.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No sharing plans for this Phase 1 study at this time.

Learn more about this trial

Safety and Tolerability of OCU-10-C-110 for Injection in Subjects With Neovascular Age-related Macular Degeneration

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