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D-4517.2 for Age-Related Macular Degeneration (Tejas Trial)

Phase 2
Recruiting
Research Sponsored by Ashvattha Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 21 days
Treatment 24 weeks
Follow Up 1 weeks
Awards & highlights

Tejas Trial Summary

This trial is testing a new drug for people with wet AMD or DME, to see if it is safe and tolerated.

Eligible Conditions
  • Age-Related Macular Degeneration
  • Diabetic Macular Edema

Tejas Trial Timeline

Screening ~ 21 days
Treatment ~ 24 weeks
Follow Up ~1 weeks
This trial's timeline: 21 days for screening, 24 weeks for treatment, and 1 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with Treatment-Emergent Adverse Events [Safety]
Secondary outcome measures
Number of participants with Ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs) observed for D-4517.2 and aflibercept
Number of participants with a reduction in sub-retinal fluid after a single intravitreal (IVT) dose of aflibercept and a single SC dose of D-4517.2
Number of participants with change in best corrected visual acuity (BCVA) in study eye after each treatment (aflibercept or D-4517.2).
+1 more

Tejas Trial Design

2Treatment groups
Experimental Treatment
Group I: Neovascular Age-related Macular DegenerationExperimental Treatment1 Intervention
Cohort A1 - 0.25 mg/kg of D-4517.2 Cohort B1 - 0.5 mg/kg of D-4517.2 Cohort C1 - 1.0 mg/kg of D-4517.2 Cohort D1 - 2.0 mg/kg of D-4517.2
Group II: Diabetic Macular EdemaExperimental Treatment1 Intervention
Cohort B2 - 0.5 mg/kg of D-4517.2 Cohort C2 - 1.0 mg/kg of D-4517.2 Cohort D2 - 2.0 mg/kg of D-4517.2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
D-4517.2
2022
Completed Phase 1
~20

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Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Ashvattha Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
109 Total Patients Enrolled
~11 spots leftby Jun 2025
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