Safety and Efficacy of AM712 in Patients with NAMD

Phase 1

Completed

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Biological: AM712(ASKG712)

• Registration Number: NCT05345769
• Lead Sponsor: AffaMed Therapeutics Limited

Brief Summary

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).

Detailed Description

The Part 1 of study is a multicenter, open-label, sequentially, multiple ascending-dose study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in subjects with nAMD.

Subjects will be sequentially enrolled into different dose-level cohorts following the traditional "3+3" design until the maximally tolerated dose (MTD) or the maximally administered dose (MAD) has been reached.

The Part 2 of study is a multicenter, open-label, sequential study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of AM712 in treatment-naïve patients with nAMD.

Study Timeline

• Study First Submitted: 2022-04-12
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-26
• Study Start: 2022-04-28
• Status Verified: 2024-11
• Primary Completion: 2024-11-04
• Study Completion: 2024-11-04
• Last Update Submitted: 2024-12-07
• Last Update Posted: 2024-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

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

Exclusion Criteria

1. Any previous systemic anti-VEGF treatment
2. Any systemic treatment or therapy to treat neovascular AMD
3. Continuous use of systemic corticosteroids
4. Diseases that affect intravenous injection and venous blood sampling
5. 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
6. 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.
7. The area of fibrosis occupies ≥ 50% of total lesion area in study eye
8. Evidence of myopia degeneration, diagnosis supported by the axial length examination in study eye
9. History or any concurrent macular abnormality other than AMD in study eye
10. Current vitreous hemorrhage or history of vitreous hemorrhage in study eye
11. History of recurrent inflammation in study eye
12. History of treatment for nAMD
13. 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Phase I- All	AM712(ASKG712)	Subjects with neovascular AMD

Primary Outcome Measures

Name	Time	Method
Incidence of non-ocular AEs	252 days	To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)
Any relevant safety observations derived from BCVA	252 days	To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)
Incidence of ocular adverse events (AEs) of the study eyes	252 days	To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)
Any relevant safety observations derived from SD-OCT	252 days	To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)

Secondary Outcome Measures

Name	Time	Method
Mean change from baseline in central subfield thickness as assessed by SD-OCT	252 days	To evaluate the efficacy of AM712 in Subjects with nAMD
Mean change from baseline in BCVA (ETDRS)	252 days	To evaluate the efficacy of AM712 in Subjects with nAMD
Proportion of patients gaining ≥ 15 letters from baseline BCVA	252 days	To evaluate the efficacy of AM712 in Subjects with nAMD
Proportion of patients with no intraretinal fluid, subretinal fluid, or pigment epithelial detachment as assessed by SD-OCT	252 days	To evaluate the efficacy of AM712 in Subjects with nAMD

Trial Locations

Locations (7)

Retina Consultants San Diego; 🇺🇸 Poway, California, United States

Bay Area Retina Associates; 🇺🇸 Walnut Creek, California, United States

Florida Eye Associates; 🇺🇸 Melbourne, Florida, United States

Colorado Retina; 🇺🇸 Lakewood, Colorado, 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; 🇺🇸 The Woodlands, Texas, United States