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Low dose AVD-104 for Diabetic Retinopathy

Phase 2

Waitlist Available

Research Sponsored by Aviceda Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of diabetes mellitus (type 1 or 2), as defined by the World Health Organization and/or American Diabetes Association

Decreased visual acuity (VA) due to DME, with BCVA letter score of 75-20 letters on ETDRS-like charts (20/32-20/320 Snellen equivalent)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months

Awards & highlights

Study Summary

This trial is testing a new treatment called AVD-104 that is injected into the eye to help reduce swelling in the macula caused by diabetic retinopathy. The purpose of the trial is to

Who is the study for?

This trial is for individuals with diabetic macular edema, a condition where fluid accumulates in the retina due to diabetes. Participants should have this specific eye swelling and not be involved in any other similar studies.Check my eligibility

What is being tested?

The study tests AVD-104 injections directly into the eye to see if they can reduce swelling caused by diabetic retinopathy. It's an early-stage (Phase 2) trial focusing on safety and how well the treatment works.See study design

What are the potential side effects?

Potential side effects of AVD-104 may include discomfort at the injection site, increased intraocular pressure, or possible vision disturbances since it involves an injection into the eye.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with diabetes (type 1 or 2).

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My vision is reduced due to diabetic eye disease, but I can still see some.

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My eye condition involves thickening of the central part of my retina.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety of AVD-104

Secondary outcome measures

Treatment effect

Treatment effect - vision

Trial Design

2Treatment groups

Experimental Treatment

Group I: Low dose AVD-104Experimental Treatment1 Intervention

Three intravitreal injections at 1.0 milligram per eye each 28 days apart will be administered to the study eye. Participants will be followed for 84 days total.

Group II: High dose AVD-104Experimental Treatment1 Intervention

Two intravitreal injections at 2.0 milligrams per eye 56 days apart will be administered to the study eye. Participants will be followed for 84 days total.

0 / 3Eligibility criteria met

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Who is running the clinical trial?

Aviceda Therapeutics, Inc.Lead Sponsor

1 Previous Clinical Trials

300 Total Patients Enrolled

Frequently Asked Questions

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

Do I meet the necessary criteria to be considered as a potential candidate for involvement in this medical study?

"To be eligible for enrollment in this clinical trial, potential participants must have a diagnosis of diabetic retinopathy and fall within the age range of 18 to 80 years old. The study aims to admit approximately 30 individuals."

Answered by AI

What is the current number of individuals being admitted into this particular medical trial?

"Indeed, the information available on clinicaltrials.gov confirms that this research study is actively seeking individuals to participate. The trial was initially posted on November 30th, 2023 and recently updated on December 12th, 2023. To complete the study successfully, a total of 30 participants are needed across three designated sites."

Answered by AI

Has the FDA granted approval for the usage of AVD-104 in high dosages?

"Based on our team's evaluation at Power, the safety rating of High dose AVD-104 is 2 due to this being a Phase 2 trial. Although there is evidence supporting its safety, no data has been found yet regarding its efficacy."

Answered by AI

Are individuals above the age of 30 eligible to participate in this study?

"To be considered eligible for this research study, applicants must fall within the age range of 18 to 80 years. It is worth noting that there are a total of 11 clinical trials available exclusively for individuals under the age of 18, and an additional 162 trials specifically targeting patients over the age of 65."

Answered by AI

Are researchers currently seeking participants for this ongoing clinical trial?

"According to the information available on clinicaltrials.gov, patient recruitment is currently ongoing for this study. The trial was initially posted on November 30th, 2023 and last updated on December 12th, 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Phase 2 Study of Intravitreal AVD-104 in Diabetic Macular Edema

2023. "A Phase 2 Study of Intravitreal AVD-104 in Diabetic Macular Edema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06181227.

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