Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
21 participants
INTERVENTIONAL
2022-04-28
2024-11-04
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase I- All
Subjects with neovascular AMD
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
50 Years
ALL
No
Sponsors
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AffaMed Therapeutics Limited
INDUSTRY
Responsible Party
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Locations
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Retina Consultants San Diego
Poway, California, United States
Bay Area Retina Associates
Walnut Creek, California, United States
Colorado Retina
Lakewood, Colorado, United States
Florida Eye Associates
Melbourne, Florida, 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
Bellaire, Texas, United States
Retina Consultants of Texas
San Antonio, Texas, United States
Retina Consultants of Texas
The Woodlands, Texas, United States
Countries
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Other Identifiers
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AM712E1001
Identifier Type: -
Identifier Source: org_study_id