D-4517.2 for Age-Related Macular Degeneration and Diabetic Macular Edema

(Tejas Trial)

Recruiting at 17 trial locations

Overseen By Jenni Herber

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ashvattha Therapeutics, Inc.

Must be taking: Anti-VEGF agents

Must not be taking: Systemic corticosteroids, Immunomodulatory treatments

Disqualifiers: Cardiac events, Uncontrolled hypertension, Chronic renal disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

50 Participants Needed

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot use certain medications like systemic corticosteroids or those toxic to the eye during the trial. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the drug D-4517.2 for Age-Related Macular Degeneration and Diabetic Macular Edema?

Research shows that similar treatments, like intravitreal injections of anti-VEGF drugs such as aflibercept and bevacizumab, have been effective in improving vision and reducing macular thickness in conditions like age-related macular degeneration and diabetic macular edema. ^{1 2 3 4 5}

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.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Stage 1: Single Dose Treatment

Single subcutaneous dose open-label assessment of safety and pharmacodynamic response to D-4517.2 in subjects with wAMD or DME

12 weeks

Visits at 2, 4, 6, 8, and 12 weeks post-dose

Stage 1A: Multiple Dose Treatment

Multiple subcutaneous dose open-label assessment of safety, pharmacokinetics, and pharmacodynamic response to D-4517.2 co-administered with Aflibercept in subjects with wAMD and DME

40 weeks

Regular visits every 2 or 4 weeks depending on cohort

Stage 2: Randomized Controlled Study

Visual examiner-masked, randomized active, sham, and placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, and efficacy of subcutaneously administered D-4517.2 to subjects with wAMD

Not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• D-4517.2

Trial Overview 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.

Participant Groups

Group I: Stage 1A wAMD Experimental Treatment 1 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 DME Experimental Treatment 1 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 wAMD Experimental Treatment 1 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 DME Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Ashvattha Therapeutics, Inc.

Lead Sponsor

Trials

4

Recruited

160+

Findings from Research

In a study involving 36 treatment-naïve patients with neovascular age-related macular degeneration (nAMD), intravitreal aflibercept injections led to a significant decrease in macular ganglion cell complex (GCC) thickness over 12 months.

The reduction in GCC thickness, particularly in the ganglion cell layer, suggests that while aflibercept is used to treat nAMD, it may also impact the structural integrity of the retina, indicating a need for careful monitoring of retinal health in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Macular ganglion cell complex changes in eyes treated with aflibercept for neovascular age-related macular degeneration. Aşikgarip, N., Temel, E., Örnek, K.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Comparing vision and macular thickness in neovascular age-related macular degeneration, diabetic macular oedema and retinal vein occlusion patients treated with intravitreal antivascular endothelial growth factor injections in clinical practice. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Intravitreal bevacizumab for treatment of neovascular age-related macular degeneration: the second year of a prospective study. [2022]

3. Pakistan pubmed.ncbi.nlm.nih.gov

Intravitreal injection of Bevacizumab in diabetic macular edema. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Macular ganglion cell complex changes in eyes treated with aflibercept for neovascular age-related macular degeneration. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Intravitreal bevacizumab for treatment of neovascular age-related macular degeneration: a one-year prospective study. [2015]