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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

Find a Location

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many medical settings are hosting this clinical investigation?

"Patients are accepted at Midwest Eye Institute - North in Indianapolis, Indiana, University Retina - Lemont in Lemont, Illinois and Retinal Consultants of San Antonio in San Antonio, Massachusetts as well as 6 other clinical trial sites."

Answered by AI

What potential adverse effects might D-4517.2 pose to patients?

"There is some evidence that D-4517.2 may be safe, so it earned a ranking of 2 on our scale. As this study has only reached Phase 2 trials there are neither efficacy nor safety data supporting its use."

Answered by AI

What are the stated objectives of this experiment?

"This 26-week trial aims to assess the safety and tolerability of a single subcutaneous dose of D-4517.2, with secondary objectives evaluating its duration of effect on subretinal fluid changes through spectral domain optical coherence tomography (SD-OCT) as well as differences in visual acuity between those receiving aflibercept or D-4517.2 treatments."

Answered by AI

What is the maximum capacity of participants for this trial?

"Ashvattha Therapeutics, Inc. require a minimum of 30 suitable patients to launch the study at multiple sites including Midwest Eye Institute - North in Indianapolis and University Retina - Lemont in Lemont."

Answered by AI

Are there still vacancies in this clinical trial available for participants?

"According to the particulars found on clinicaltrials.gov, this medical research is presently in search of participants; it was initially posted on August 31st 2022 and subsequently updated a few weeks later on September 19th."

Answered by AI

Who else is applying?

What state do they live in?
California
What site did they apply to?
Lazar Retina
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Most responsive sites:
  1. Lazar Retina: < 48 hours
Typically responds via
Email
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of D-4517.2 After Subcutaneous Administration in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (AMD) or Subjects With Diabetic Macular Edema (DME)
2022. "A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of D-4517.2 After Subcutaneous Administration in Subjects With Neovascular (Wet) Age-Related Macular Degeneration (AMD) or Subjects With Diabetic Macular Edema (DME)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05387837.
All > Macular Edema > Macular Degeneration
~12 spots leftby Apr 2025
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