Phase I- All for Neovascular Age-related Macular Degeneration

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Retina Consultants San Diego, Poway, CA
Neovascular Age-related Macular Degeneration+2 More
AM712(ASKG712) - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The purpose of this Phase 1 study is comprised of multiple ascending-dose component (Part 1) and dose-expansion cohorts component (Part 2) to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in patients with neovascular age- related macular degeneration (nAMD).

Eligible Conditions

  • Neovascular Age-related Macular Degeneration

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Neovascular Age-related Macular Degeneration

Study Objectives

4 Primary · 4 Secondary · Reporting Duration: 112 days

112 days
Any relevant safety observations derived from BCVA
Any relevant safety observations derived from SD-OCT
Incidence of non-ocular AEs
Incidence of ocular adverse events (AEs) of the study eyes
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
Proportion of patients with no intraretinal fluid, subretinal fluid, or pigment epithelial detachment as assessed by SD-OCT

Trial Safety

Safety Progress

1 of 3

Other trials for Neovascular Age-related Macular Degeneration

Trial Design

1 Treatment Group

Phase I- All
1 of 1
Experimental Treatment

24 Total Participants · 1 Treatment Group

Primary Treatment: Phase I- All · No Placebo Group · Phase 1

Phase I- All
Biological
Experimental Group · 1 Intervention: AM712(ASKG712) · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 112 days
Closest Location: Retina Consultants San Diego · Poway, CA
2006First Recorded Clinical Trial
1 TrialsResearching Neovascular Age-related Macular Degeneration
3 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a sub-foveal CNV lesion secondary to nAMD.
A letter score of 6 or more is required.

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.