Clinical Study of ALT-L9 to Determine Safety, Efficacy and Pharmacokinetics in Neovascular AMD

NCT04058535 | Completed Phase 1 DMC

• 1 other identifier: ALT-L9-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, efficacy and pharmacokinetics of repeated intravitreal administration of ALT-L9 2 mg/50uL compared with Eylea in patients with neovascular Age-related macular degeneration.

Conditions

Neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Occurrences of adverse events

  Check the adverse events in study eye at the assessment points after triple administration

  8 weeks

Study Arms (2)

ALT-L9

EXPERIMENTAL

Intravitreal injection of ALT-L9 50 ul, every 4 weeks

Biological: ALT-L9

Eylea

ACTIVE COMPARATOR

Intravitreal injection of Eylea 50 ul, every 4 weeks

Biological: Eylea

Interventions

Eylea BIOLOGICAL

Aflibercept

Eylea

ALT-L9 BIOLOGICAL

Aflibercept biosimilar

ALT-L9

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 50years old or more at the time of consent.
• Patients with any history of anti-VEGF treatment(Aflibercept, Bevacizumab, Ranibizumab) for neovascular AMD in the study eye.
• Patients who were treated with the last anti-VEGF at least 8 weeks prior to study drug administration.
• Patients with untreated active primary subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA, ICGA, and/or SD-OCT in the study eye at the start of the screening visit.
• Patients with subretinal, intraretinal, or subretinal pigment epithelium fluid as assessed by SD-OCT in the study eye at the start of the screening visit.
• Patients with ETDRS best-corrected visual acuity of 20/40 to 20/320 (letter score of 73 to 25) in the study eye at the start of the administration of the study drug.
• Patients with ETDRS best-corrected visual acuity of 20/400 (letter score 20) or better in the fellow eye at the start of the administration of the study drug.
• Patients who provide written informed consent to participate in this clinical study

You may not qualify if:

• Patients who have received any prior ocular (in the study eye) or systemic treatment for neovascular AMD within 8 weeks from the baseline date except dietary supplements or vitamins.
• Patients who have received any surgery for neovascular AMD.
• Patients with any current or history of macular or retinal disease other than neovascular AMD (eg, diabetic macular edema, retinal vein occlusion, pathological myopia, angioid streaks, ocular histoplasmosis, trauma, retinal detachment, epiretinal membrane, macular hole, central serous chorioretinopathy, Choroidal rupture, Multiple network choroiditis, proliferative diabetic retinopathy) in the study eye.
• Patients with scar, fibrosis, or atrophy involving the center of the fovea in the study eye that might interfere with visual acuity.
• Patients with hemorrhage under the fovea or subretinal hemorrhage 50% or more of the total lesion area in the study eye.
• Patients with retinal pigment epithelial tears or rips involving the macula in the study eye.
• Patients with a history of any vitreous hemorrhage or rhegmatogenous retinal detachment in the study eye within 4 weeks before the start of the administration of the study drug.
• Patients who have received panretinal photocoagulation in the study eye.
• Patients who have received vitreous surgery in the study eye.
• Patients with a history of corneal transplant or corneal dystrophy in the study eye.
• Patients who have received cataract surgery or Lasik in the study eye within 90 days before the start of the administration of the study drug.
• Patients who have received trabeculectomy or other filtration surgery in the study eye
• Patients with poorly controlled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye.
• Patients with significant media opacities, including cataract, in the study eye that might interfere with visual acuity, assessment of safety, or fundus photography considered by the principal investigator or investigator.
• Patients with any diseases in the study eye that could have compromised visual acuity such as amblyopia and anterior ischemic optic neuropathy considered by the principal investigator or investigator.

Sponsors & Collaborators

• Alteogen, Inc.: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Interventions

aflibercept

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 15, 2019
• Study Start: February 5, 2020
• Primary Completion: December 22, 2020
• Study Completion: December 22, 2020
• Last Updated: January 20, 2022

Record last verified: 2022-01

Locations

KR (1)