Clinical trial NCT05345769: Safety and Efficacy of AM712 in Patients with NAMD
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neovascular Age-related Macular Degeneration
Keywords: nAMD
Lead sponsor: AffaMed Therapeutics Limited
Sponsor class: INDUSTRY
First posted: 2022-04-26
Enrollment: 21
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of ocular adverse events (AEs) of the study eyes
timeFrame: 252 days
measure: Incidence of non-ocular AEs
timeFrame: 252 days
measure: Any relevant safety observations derived from BCVA
timeFrame: 252 days
measure: Any relevant safety observations derived from SD-OCT
timeFrame: 252 days
Secondary outcomes:
measure: Mean change from baseline in central subfield thickness as assessed by SD-OCT
timeFrame: 252 days
measure: Proportion of patients with no intraretinal fluid, subretinal fluid, or pigment epithelial detachment as assessed by SD-OCT
timeFrame: 252 days
measure: Mean change from baseline in BCVA (ETDRS)
timeFrame: 252 days
measure: Proportion of patients gaining ≥ 15 letters from baseline BCVA
timeFrame: 252 days
Other outcomes:
Locations:
city: Poway
country: United States
facility: Retina Consultants San Diego
state: California
city: Walnut Creek
country: United States
facility: Bay Area Retina Associates
state: California
city: Lakewood
country: United States
facility: Colorado Retina
state: Colorado
city: Melbourne
country: United States
facility: Florida Eye Associates
state: Florida
city: Springfield
country: United States
facility: Retina Research Institute at New England Retina Consultants
state: Massachusetts
city: Nashville
country: United States
facility: Tennessee Retina, PC
state: Tennessee
city: Bellaire
country: United States
facility: Retina Consultants of Texas
state: Texas
city: San Antonio
country: United States
facility: Retina Consultants of Texas
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Texas
state: Texas
Study officials:
References: