ClinicalTrials.Veeva

Menu
The trial is taking place at:
R

Retina Consultants San Diego | Poway, CA

Veeva-enabled site

Safety and Efficacy of AM712 in Patients With nAMD

A

AffaMed Therapeutics

Status and phase

Enrolling
Phase 1

Conditions

Neovascular Age-related Macular Degeneration

Treatments

Biological: AM712(ASKG712)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05345769
AM712E1001

Details and patient eligibility

About

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).

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

Phase I- All
Experimental group
Description:
Subjects with neovascular AMD
Treatment:
Biological: AM712(ASKG712)

Trial contacts and locations

9

Loading...

Central trial contact

Fan Yang

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems