Safety and Efficacy of AM712 in Patients With nAMD

Neovascular Age-related Macular Degeneration Clinical Trial

Official title:

A Prospective, Multi-Center, Open-label, Sequential, Multiple Ascending-Dose and High Concentration Cohorts Phase 1 Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of AM712 Following Intravitreal Administration in Patients With Neovascular Age-related Macular Degeneration.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05345769
• Other study ID #: AM712E1001
• Status: Recruiting
• Phase: Phase 1
• Start date: April 28, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: July 2023
• Source: AffaMed Therapeutics Limited
• Contact: Fan Yang
• Phone: +1 (306) 580-5857
• Email: fan.yang[@]affamed.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Biological:
• AM712(ASKG712)
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AffaMed Therapeutics (US) Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Incidence of non-ocular AEs	To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)	252 days
Primary	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
Primary	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	Mean change from baseline in central subfield thickness as assessed by SD-OCT	To evaluate the efficacy of AM712 in Subjects with nAMD	252 days
Secondary	Proportion of patients with no intraretinal fluid, subretinal fluid, or pigment epithelial detachment as assessed by SD-OCT	To evaluate the efficacy of AM712 in Subjects with nAMD	252 days
Secondary	Mean change from baseline in BCVA (ETDRS)	To evaluate the efficacy of AM712 in Subjects with nAMD	252 days
Secondary	Proportion of patients gaining = 15 letters from baseline BCVA	To evaluate the efficacy of AM712 in Subjects with nAMD	252 days