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Anti-VEGF Antibody

Low Dose for Age-Related Macular Degeneration (DISCOVER Trial)

Phase 1 & 2

Recruiting

Research Sponsored by AsclepiX Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Presence of active subfoveal choroidal neovascularization (CNV) (any subtype) or juxtafoveal CNV with leakage affecting the fovea secondary to AMD and the area of the CNV lesion must beat least 50% of the total lesion size confirmed by the Investigator Evidence of subretinal or intraretinal fluid or retinal cystic changes evidenced by Spectral Domain Optical Coherence Tomography (SD-OCT) at Screening accompanied by finding on SD- OCT suggestive of CNV secondary to AMD confirmed by the Investigator BCVA in the study eye between 65 and 25 ETDRS letters (20/50 and 20/320 Snellen equivalent) at Baseline (Day 0)

50 years of age or older

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 40 weeks

Awards & highlights

DISCOVER Trial Summary

This trial is testing the safety of a drug called AXT107 when injected into the eye of people with a certain eye condition. The trial will also look at how long the drug stays active in the

Who is the study for?

This trial is for people over 50 with a type of vision loss called nAMD. They must have certain types of eye fluid or changes seen on an eye scan, and their vision should be within a specific range. Participants also need to have had some response to previous treatments that target VEGF, a protein related to blood vessel growth.Check my eligibility

What is being tested?

The study tests three doses of AXT107 given as an injection into the eye area in patients with nAMD. It aims to find out how safe the drug is at its highest dose that can be tolerated and how well it works over nine months after just one injection.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include discomfort or complications from the injection process itself, inflammation inside the eye, increased intraocular pressure, and possible impact on visual acuity.

DISCOVER Trial Eligibility Criteria

Inclusion Criteria

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

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I have AMD with specific vision loss and confirmed CNV affecting my central vision.

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I am 50 years old or older.

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I previously had some response to anti-VEGF treatment.

DISCOVER Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 40 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~40 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 40 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

Incidence of Treatment-Emergent Adverse Events

Secondary outcome measures

Mean Change in Central Subfield Thickness (CST)

Mean Change in Visual Function

Visual Function Subgroup Analysis

DISCOVER Trial Design

3Treatment groups

Experimental Treatment

Group I: Mid DoseExperimental Treatment1 Intervention

AXT107 0.250 mg/eye

Group II: Low DoseExperimental Treatment1 Intervention

AXT107 0.125 mg/eye

Group III: High DoseExperimental Treatment1 Intervention

AXT107 0.500 mg/eye

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AsclepiX Therapeutics, Inc.Lead Sponsor

2 Previous Clinical Trials

9 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 requirements to be considered as a potential candidate for this medical study?

"To qualify for this clinical trial, individuals must have a diagnosis of age-related macular degeneration and fall within the age range of 50 to 99. The study aims to recruit a total of 15 eligible participants."

Answered by AI

Is the clinical trial inclusive of individuals who have surpassed their second decade of life?

"To be eligible for participation in this study, applicants must fall within the age range of 50 to 99. It is worth noting that there are a total of 8 studies available for individuals under the age of 18 and an additional 169 studies specifically targeting those over the age of 65."

Answered by AI

Are there any available positions for patients in this ongoing clinical trial?

"Affirmative. The details obtained from clinicaltrials.gov indicate that this particular clinical trial is presently in the process of seeking suitable candidates for participation. As per the information provided, the trial was initially posted on December 19th, 2023 and most recently updated on December 24th, 2023. To complete enrollment, a total of 15 patients are being recruited exclusively at one designated site."

Answered by AI

What is the current number of individuals undergoing treatment in this medical study?

"Indeed, the details provided on clinicaltrials.gov indicate that this trial is actively seeking eligible participants. The initial posting date was December 19th, 2023, and the most recent update occurred on December 24th, 2023. There is a need to recruit a total of 15 patients from one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)

2023. "Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05859776.