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Monoclonal Antibodies

AM712 for Age-Related Macular Degeneration

Phase 1
Recruiting
Research Sponsored by AffaMed Therapeutics (US) Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clear ocular media and adequate pupil dilation to permit good quality photographic imaging in study eye
Male or female subjects with 50 years of age or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 252 days
Awards & highlights

Study Summary

This trial is testing a new drug for age-related macular degeneration to see if it is safe and effective.

Who is the study for?
This trial is for men and women over 50 with a specific eye condition called neovascular age-related macular degeneration (nAMD). Participants must have certain characteristics in their eye lesions and vision clarity. They can't join if they use systemic steroids, have other eye diseases or conditions that could interfere with the study, or if they've had previous treatments for nAMD.Check my eligibility
What is being tested?
The trial tests AM712's safety and effectiveness in two parts: one where doses increase to find the right amount (Part 1) and another testing a high concentration of the drug (Part 2). It aims to see how well patients tolerate it, its effects on their bodies, and how it might improve nAMD.See study design
What are the potential side effects?
Since this is an early-phase trial for AM712, potential side effects are being studied. Common risks may include irritation at injection site, allergic reactions, changes in vision or eye discomfort. The full profile will be clearer after more research.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My eyes can be clearly photographed for the study.
Select...
I am 50 years old or older.
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I have a specific type of wet age-related macular degeneration affecting my central vision.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~252 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 252 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Any relevant safety observations derived from BCVA
Any relevant safety observations derived from SD-OCT
Incidence of non-ocular AEs
+1 more
Secondary outcome measures
Mean change from baseline in BCVA (ETDRS)
Mean change from baseline in central subfield thickness as assessed by SD-OCT
Proportion of patients gaining ≥ 15 letters from baseline BCVA
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Phase I- AllExperimental Treatment1 Intervention
Subjects with neovascular AMD

Find a Location

Who is running the clinical trial?

AffaMed Therapeutics (US) Inc.Lead Sponsor

Media Library

AM712 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05345769 — Phase 1
Age-Related Macular Degeneration Research Study Groups: Phase I- All
Age-Related Macular Degeneration Clinical Trial 2023: AM712 Highlights & Side Effects. Trial Name: NCT05345769 — Phase 1
AM712 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05345769 — Phase 1

Frequently Asked Questions

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

Are there any American locations carrying out this research study?

"This trial is utilizing the expertise of 10 different medical centres, including Florida Eye Associates in Melbourne, Colorado Retina in Lakewood and Tennessee Retina, PC in Nashville."

Answered by AI

What is the main purpose of this trial?

"This medical trial spans 112 days, with the primary outcome being a measure of any adverse ocular effects. Secondary outcomes include changes in central subfield thickness as assessed by SD-OCT, proportion of patients lacking intraretinal fluid or pigment epithelial detachment (also determined through SD-OCT), and mean change from baseline regarding visual acuity on ETDRS tests."

Answered by AI

Is recruitment for this study still open?

"Evident from clinicaltrials.gov, this medical experiment is presently enrolling patients and was initially posted on April 28th 2022; the last update to its data occurred on August 9th of that same year."

Answered by AI

Could you elucidate the potential risks of taking AM712 (ASKG712)?

"Due to its Phase 1 status, the safety of AM712(ASKG712) is tentatively rated a 1. There exists minimal evidence thus far supporting efficacy and limited data on potential risks."

Answered by AI

How many participants are involved in the current experiment?

"Confirmative. According to clinicaltrials.gov, the advertised medical study is presently enrolling participants. This project was published on April 28th 2022 and has been amended as recently as August 9th 2022. 24 volunteers are being sought from nine different sites."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Efficacy of AM712 in Patients With nAMD
2022. "Safety and Efficacy of AM712 in Patients With nAMD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05345769.
All > Age Related Macular Degeneration > Wet Macular Degeneration
~2 spots leftby Jun 2024
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