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Safety and Efficacy of AM712 in Patients With nAMD

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ClinicalTrials.gov Identifier: NCT05345769
Recruitment Status : Recruiting
First Posted : April 26, 2022
Last Update Posted : July 25, 2023
Sponsor:
Information provided by (Responsible Party):
AffaMed Therapeutics Limited ( AffaMed Therapeutics (US) Inc. )

Study Description
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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).

Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Biological: AM712(ASKG712) Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: 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).
Primary Purpose: Treatment
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.
Actual Study Start Date : April 28, 2022
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Phase I- All
Subjects with neovascular AMD
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of ocular adverse events (AEs) of the study eyes [ Time Frame: 252 days ]
    To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)

  2. Incidence of non-ocular AEs [ Time Frame: 252 days ]
    To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)

  3. Any relevant safety observations derived from BCVA [ Time Frame: 252 days ]
    To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)

  4. Any relevant safety observations derived from SD-OCT [ Time Frame: 252 days ]
    To evaluate the safety and tolerability of AM712 in Subjects with neovascular Age-related Macular Degeneration (nAMD)


Secondary Outcome Measures :
  1. Mean change from baseline in central subfield thickness as assessed by SD-OCT [ Time Frame: 252 days ]
    To evaluate the efficacy of AM712 in Subjects with nAMD

  2. Proportion of patients with no intraretinal fluid, subretinal fluid, or pigment epithelial detachment as assessed by SD-OCT [ Time Frame: 252 days ]
    To evaluate the efficacy of AM712 in Subjects with nAMD

  3. Mean change from baseline in BCVA (ETDRS) [ Time Frame: 252 days ]
    To evaluate the efficacy of AM712 in Subjects with nAMD

  4. Proportion of patients gaining ≥ 15 letters from baseline BCVA [ Time Frame: 252 days ]
    To evaluate the efficacy of AM712 in Subjects with nAMD


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05345769


Contacts
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Contact: Fan Yang +1 (306) 580-5857 fan.yang@affamed.com

Locations
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United States, California
Retina Consultants San Diego Recruiting
Poway, California, United States, 92064
Contact: Nikolas London         
Bay Area Retina Associates Recruiting
Walnut Creek, California, United States, 94598
Contact: Roger Goldberg         
United States, Colorado
Colorado Retina Suspended
Lakewood, Colorado, United States, 80228
United States, Florida
Florida Eye Associates Recruiting
Melbourne, Florida, United States, 32901
Contact: Vrinda Hershberger         
United States, Massachusetts
Retina Research Institute at New England Retina Consultants Recruiting
Springfield, Massachusetts, United States, 01107
Contact: David Lally         
United States, Tennessee
Tennessee Retina, PC Recruiting
Nashville, Tennessee, United States, 37203
Contact: Eric W. Schneider         
United States, Texas
Retina Consultants of Texas Recruiting
Bellaire, Texas, United States, 77401
Contact: David M. Brown         
Retina Consultants of Texas Recruiting
San Antonio, Texas, United States, 78240
Contact: Gary Lane         
Retina Consultants of Texas Recruiting
The Woodlands, Texas, United States, 77384
Contact: Charles C. Wykoff         
Sponsors and Collaborators
AffaMed Therapeutics (US) Inc.
More Information
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Responsible Party: AffaMed Therapeutics (US) Inc.
ClinicalTrials.gov Identifier: NCT05345769    
Other Study ID Numbers: AM712E1001
First Posted: April 26, 2022    Key Record Dates
Last Update Posted: July 25, 2023
Last Verified: July 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AffaMed Therapeutics Limited ( AffaMed Therapeutics (US) Inc. ):
nAMD
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases