Safety and Efficacy of AM712 in Patients with NAMD

Completed · Phase 1

Conditions studied: Neovascular Age-related Macular Degeneration

In brief

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

Key facts

Study ID

NCT05345769

Run by

AffaMed Therapeutics Limited

People needed

21

Starts

2022-04-28

Expected to finish

2024-11-04

Last updated by the study team

2024-12-12

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female subjects with 50 years of age or older
• Active sub-foveal CNV lesion secondary to nAMD including juxta or extra-foveal lesions that partially affect the fovea
• The area of CNV must occupy at least 50% of total lesion
• Total lesion area ≤ 12 DA
• ETDRS BCVA letter score measured at screening and baseline
• Clear ocular media and adequate pupil dilation to permit good quality photographic imaging in study eye

You may not qualify if…

• Any previous systemic anti-VEGF treatment
• Any systemic treatment or therapy to treat neovascular AMD
• Continuous use of systemic corticosteroids
• Diseases that affect intravenous injection and venous blood sampling
• Presence of CNV due to other causes, such as ocular histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, or pathologic myopia in study eye
• History or any concurrent ocular condition which, in opinion of investigator, could either confound interpretation of efficacy and safety of IP or require medical or surgical intervention.
• The area of fibrosis occupies ≥ 50% of total lesion area in study eye
• Evidence of myopia degeneration, diagnosis supported by the axial length examination in study eye
• History or any concurrent macular abnormality other than AMD in study eye
• Current vitreous hemorrhage or history of vitreous hemorrhage in study eye
• History of recurrent inflammation in study eye
• History of treatment for nAMD
• Subject having out of range laboratory values defined as:
• ALT or AST > 2 x ULN, total bilirubin > 1.5 x ULN Serum creatinine > 1.5 x ULN, BUN > 2 x ULN HbA1c > 7.5% at screening

Where it is running

• Retina Consultants San Diego — Poway, California, United States
• Bay Area Retina Associates — Walnut Creek, California, United States
• Colorado Retina — Lakewood, Colorado, United States
• Florida Eye Associates — Melbourne, Florida, United States
• Retina Research Institute at New England Retina Consultants — Springfield, Massachusetts, United States
• Tennessee Retina, PC — Nashville, Tennessee, United States
• Retina Consultants of Texas — Bellaire, Texas, United States
• Retina Consultants of Texas — San Antonio, Texas, United States
• Retina Consultants of Texas — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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