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D-4517.2 for Age-Related Macular Degeneration and Diabetic Macular Edema (Tejas Trial)
Phase 2
Waitlist Available
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 week
Awards & highlights
No Placebo-Only Group
Summary
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.
Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
While specific side effects are not listed here, common ones related to subcutaneous injections may include pain at injection site, swelling, bruising and possible allergic reactions. The drug's safety profile will be closely monitored throughout the trial.
Timeline
Screening ~ 21 days1 visit
Treatment ~ 24 weeks14 visits
Follow Up ~ 1 week1 visit
Screening ~ 21 days
Treatment ~ 24 weeks
Follow Up ~1 week
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Stage 1 Safety Evaluation
Stage 1A Safety Evaluation
Secondary study objectives
Stage 1: Number of participants with Ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs) observed for D-4517.2 and aflibercept
Stage 1: 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
Stage 1: Number of participants with change in best corrected visual acuity (BCVA) in study eye after each treatment (aflibercept or D-4517.2).
+7 moreSide effects data
From 2020 Phase 4 trial • 26 Patients • NCT030222924%
Retinal detachment
4%
Myelodysplastic syndrome
4%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
IAI Treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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
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