Status:
COMPLETED
Safety and Efficacy of AM712 in Patients with NAMD
Lead Sponsor:
AffaMed Therapeutics Limited
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
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 effic...
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. Subj...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05345769
Start Date
April 28 2022
End Date
November 4 2024
Last Update
December 12 2024
Active Locations (9)
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1
Retina Consultants San Diego
Poway, California, United States, 92064
2
Bay Area Retina Associates
Walnut Creek, California, United States, 94598
3
Colorado Retina
Lakewood, Colorado, United States, 80228
4
Florida Eye Associates
Melbourne, Florida, United States, 32901