AzTrials
AzTrials

Neovascular Age-related Macular DegenerationPhase 1NCT04058535

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

A Phase 1 study testing Eylea and ALT-L9 in people with Neovascular Age-related Macular Degeneration, run by Alteogen, Inc. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Eylea and ALT-L9
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
1 siteSouth Korea
Study dates
5 Feb 2020to 22 Dec 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 38Show fewer
  • 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.
  • Patients with cataract in the study eye that could have required medical or surgical intervention during the course of the study considered by the principal investigator or investigator.
  • Patients with aphakia with absence of posterior capsule in the study eye.
  • Patients who have received therapeutic radiation in the region of the study eye.
  • Patients who use topical ocular corticosteroids for 30, or more, consecutive days within 90 days before the screening visit, or have a plan or actual use for 30 or more consecutive days during the course of the study in the study eye.
  • Criteria for fellow eye or either eye:
  • Patients with any active intraocular or periocular infection or intraocular inflammation in either eye (eg, infectious blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis).
  • Patients with a history of uveitis in either eye.
  • Patients with a concurrent or history of scleromalacia in either eye.
  • Patients who have received anti-VEGF medication in the fellow eye within 8 weeks before the start of the administration of the study drug.
  • Other criteria:
  • Patients who use systemic corticosteroids for 30 or more consecutive days within 90 days before the Screening Visit, or have a plan or actual use for 30 or more consecutive days during the course of the study. Inhaled steroids were permitted.
  • Patients who use steroid(except systemic or inhaled steroid) within 6 months, or have a plan for use of steroid during the course of the study.
  • Patients with poorly controlled hypertension. (defined as systolic BP is 160 mmHg or more or diastolic BP is 100 mmHg or more despite medication)
  • Patients with a serious liver, kidney or cardiovascular disorders considered by the principal investigator or investigator.
  • Patients with a concurrent or history of malignancy within 5 years before informed consent.
  • Patients with drug abuse (defined as use of illegal drugs) or alcohol dependence or a history of these conditions.
  • Patients with a history of clinically significant drug hypersensitivity.
  • Patients with a history of allergy to aflibercept, fluorescein, indocyanine green and povidone iodine.
  • Patients with any contraindications described in aflibercept package insert.
  • Females who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study.
  • Patients with type 1 diabetes or increase of HbA1c(>12%).
  • Patients who have received any other investigational drug within 12 weeks before screening visit.
  • Other patients considered by the principal investigator or investigator to be inappropriate as subjects.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Seoul National University Hospital

    Seoul

Other trials in South Korea

About this study

Official title: A Phase I Clinical Study of ALT-L9 in Patients With Neovascular Age-related Macular Degeneration

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.

Being tested
Eylea, ALT-L9

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EyleaBiological

    Aflibercept

  • ALT-L9Biological

    Aflibercept biosimilar

Study groups in NCT04058535
Study groupRoleWhat they receive
ALT-L9ExperimentalIntravitreal injection of ALT-L9 50 ul, every 4 weeks
Receives: Biological: ALT-L9
EyleaActive comparatorIntravitreal injection of Eylea 50 ul, every 4 weeks
Receives: Biological: Eylea

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrences of adverse events

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

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2019
  2. Study start5 Feb 2020
  3. Primary completion22 Dec 2020
  4. Study completion22 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04058535
Sponsor's protocol ID
ALT-L9-01
Status last verified
Jan 2022
First submitted
14 Aug 2019
Last updated
20 Jan 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Eylea and ALT-L9 in people with Neovascular Age-related Macular Degeneration, run by Alteogen, Inc. at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrences of adverse events (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04058535.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in