D-4517.2 for Age-Related Macular Degeneration and Diabetic Macular Edema
(Tejas Trial)
Recruiting at 16 trial locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Waitlist Available
Sponsor: Ashvattha Therapeutics, Inc.
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?
This trial tests a new injectable drug, D-4517.2, in people with wet AMD or DME. The drug aims to block a protein that causes harmful blood vessel growth in the eye, potentially preventing further vision loss.
Eligibility Criteria
This trial is for adults with wet Age-Related Macular Degeneration (AMD) or Diabetic Macular Edema (DME). Participants must have shown improvement after previous anti-VEGF treatments, agree to contraception if of childbearing potential, and be likely to complete the study. Exclusions include uncontrolled blood pressure or diabetes, certain allergies, recent heart attacks or strokes, and other serious health conditions.Inclusion Criteria
The doctor will check if you meet these requirements in the first stage of the study.
You agree to not have sexual intercourse during the study and 30 days after the last dose of the study drug OR you agree to use two reliable forms of birth control during the study, including at least one physical barrier method, for 30 days after the last dose of the study drug.
You cannot donate sperm for a month after finishing the study.
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Exclusion Criteria
Must have no history of Treatment of either DME or DR with macular laser
Patients with uncontrolled high blood pressure and/or diabetes will not be eligible.
Known allergy to constituents of the study drug formulation, Aflibercept, or clinically relevant hypersensitivity to fluorescein used by the patient during the study
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Treatment Details
Interventions
- D-4517.2 (Other)
Trial OverviewThe trial tests a new medication called D-4517.2 administered under the skin for people with wet AMD or DME. It aims to evaluate safety, how well it's tolerated by patients, and how the body processes it.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: Stage 1A wAMDExperimental Treatment1 Intervention
* Cohort E1 - 2.0 mg/kg of D-4517.2 every 2 weeks
* Cohort F1 - 2.0 mg/kg of D-4517.2 every 4 weeks
Group II: Stage 1A DMEExperimental Treatment1 Intervention
* Cohort E2 - 2.0 mg/kg of D-4517.2 every 2 weeks
* Cohort F2 - 2.0 mg/kg of D-4517.2 every 4 weeks
Group III: Stage 1 wAMDExperimental Treatment1 Intervention
* Cohort A1 - 0.18 mg/kg of D-4517.2
* Cohort B1 - 0.36 mg/kg of D-4517.2
* Cohort C1 - 0.71 mg/kg of D-4517.2
* Cohort D1 - 1.5 mg/kg of D-4517.2
Group IV: Stage 1 DMEExperimental Treatment1 Intervention
* Cohort B2 - 0.36 mg/kg of D-4517.2
* Cohort C2 - 0.71 mg/kg of D-4517.2
* Cohort D2 - 1.5 mg/kg of D-4517.2
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ashvattha Therapeutics, Inc.
Lead Sponsor
Trials
4
Recruited
160+