D-4517.2 for Macular Edema

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University Retina - Lemont, Lemont, IL
Macular Edema+4 More
D-4517.2 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

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)

Eligible Conditions

  • Macular Edema
  • Age related macular degeneration
  • Diabetic Macular Edema (DME)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Macular Edema

Study Objectives

2 Primary · 8 Secondary · Reporting Duration: Within subject, central subfield thickness (CST) in study eye after IVT aflibercept and D-4517.2 at 2, 4, 6, 8, and 12 weeks post-dose as assessed by SD-OCT.

Week 12
Number of participants with Ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs) observed for D-4517.2 and aflibercept
Ocular and non-ocular adverse events (AEs) and serious adverse events (SAEs) observed for D-4517.2 and aflibercept.
Week 12
Change in best corrected visual acuity (BCVA) in study eye after each treatment (aflibercept or 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).
Week 26
Number of participants with Treatment-Emergent Adverse Events [Safety]
Safety of a single subcutaneous (SC) dose of D-4517.2 in subjects with neovascular (wet) AMD and subjects with DME as assessed by CTCAE V.5.
Week 12
Duration of effect of D-4517.2 as assessed by changes in subretinal fluid over time up to 12 weeks.
Number of participants with duration of effect of D-4517.2 as assessed by changes in subretinal fluid over time up to 12 weeks
Week 12
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
To compare reduction in sub-retinal fluid after a single intravitreal (IVT) dose of aflibercept and a single SC dose of D-4517.2 in each subject.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Macular Edema

Trial Design

2 Treatment Groups

Diabetic Macular Edema
1 of 2
Neovascular Age-related Macular Degeneration
1 of 2
Experimental Treatment

30 Total Participants · 2 Treatment Groups

Primary Treatment: D-4517.2 · No Placebo Group · Phase 2

Diabetic Macular Edema
Drug
Experimental Group · 1 Intervention: D-4517.2 · Intervention Types: Drug
Neovascular Age-related Macular Degeneration
Drug
Experimental Group · 1 Intervention: D-4517.2 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
D-4517.2
2022
Completed Phase 1
~20

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within subject, central subfield thickness (cst) in study eye after ivt aflibercept and d-4517.2 at 2, 4, 6, 8, and 12 weeks post-dose as assessed by sd-oct.
Closest Location: University Retina - Lemont · Lemont, IL
Photo of illinois 1Photo of illinois 2Photo of illinois 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Macular Edema
0 CompletedClinical Trials

Who is running the clinical trial?

Ashvattha Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
325 Total Patients Enrolled
1 Trials studying Macular Edema
16 Patients Enrolled for Macular Edema

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are willing and able to give informed consent, comply with all study procedures, and be likely to complete the study.
You have a diagnosis of exudative age-related macular degeneration.
Increase in BCVA of greater than or equal to 2 lines from initial diagnosis using Snellen scale.
You must agree not to donate sperm during study and for 30 days following administration of the last dose of IP.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.