Safety and Efficacy of AM712 in Patients with NAMD

NCT05345769 | Completed Phase 1 FDA Drug

• 1 other identifier: AM712E1001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 9

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).

Conditions

Neovascular Age-related Macular Degeneration

Keywords

nAMD

Outcome Measures

Primary Outcomes (4)

• Incidence of ocular adverse events (AEs) of the study eyes

  To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)

  252 days

• Incidence of non-ocular AEs

  To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)

  252 days

• Any relevant safety observations derived from BCVA

  To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)

  252 days

• Any relevant safety observations derived from SD-OCT

  To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)

  252 days

Secondary Outcomes (4)

• Mean change from baseline in central subfield thickness as assessed by SD-OCT

  252 days

• Proportion of patients with no intraretinal fluid, subretinal fluid, or pigment epithelial detachment as assessed by SD-OCT

  252 days

• Mean change from baseline in BCVA (ETDRS)

  252 days

• Proportion of patients gaining ≥ 15 letters from baseline BCVA

  252 days

Study Arms (1)

Phase I- All

EXPERIMENTAL

Subjects with neovascular AMD

Biological: AM712(ASKG712)

Interventions

AM712(ASKG712) BIOLOGICAL

AM712 is a recombinant anti-VEGF humanized monoclonal antibody and Ang-2 antagonist peptide fusion protein, which has high specificity for the binding of VEGF-A and Ang-2.

Phase I- All

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• AffaMed Therapeutics Limited: lead

Study Sites (9)

Retina Consultants San Diego

Poway, California, 92064, United States

Location

Bay Area Retina Associates

Walnut Creek, California, 94598, United States

Location

Colorado Retina

Lakewood, Colorado, 80228, United States

Location

Florida Eye Associates

Melbourne, Florida, 32901, United States

Location

Retina Research Institute at New England Retina Consultants

Springfield, Massachusetts, 01107, United States

Location

Tennessee Retina, PC

Nashville, Tennessee, 37203, United States

Location

Retina Consultants of Texas

Bellaire, Texas, 77401, United States

Location

Retina Consultants of Texas

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Texas

The Woodlands, Texas, 77384, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: The Phase 1 study is comprised of open-label 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).
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2022
• First Posted: April 26, 2022
• Study Start: April 28, 2022
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: December 12, 2024

Record last verified: 2024-11

Locations

US (9)