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CompletedNCT04058535Updated Jan 20, 2022

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

A Phase 1 interventional study of Eylea and ALT-L9 in Neovascular Age-related Macular Degeneration, sponsored by Alteogen, Inc.. Completed at 1 site in Korea, Republic of. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2022-01-20.

Sponsored by Alteogen, Inc. · Phase 1, Interventional, and Treatment

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Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 67 studies in Macular Degeneration with a site in Korea, Republic of — 11 open to participants now, 13 under way, 5 of them phase 3. Macular Degeneration · Korea, Republic of.

Enrollment
45th of 56
28 · median 81
Started
2020
with 5 others
Phase 1
6 of 67
none open now
Registered
33rd of 67
by date

Among the 67 studies in Macular Degeneration with a site in Korea, Republic of, this one is the 45th largest by enrollment of the 56 interventional ones that give a count, is one of 6 that started in 2020, is one of 6 in phase 1, and was the 33rd registered.

Macular Degeneration

1,459 studies on the registry are indexed under Macular Degeneration; 236 are open to participants now.

Browse Macular Degeneration studies →

Open to participants now

11 of the 67 studies in Macular Degeneration with a site in Korea, Republic of are open now. Recruiting first, the newest first:

6 more — sign in →

All 11 open studies →

A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →

Who these studies take

Of the 165 Macular Degeneration studies recruiting now, 116 (70%) set no upper age limit and 5 (3%) stop at 75 or younger; 19 take children under 18; 35 take healthy volunteers.

This study: 50 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 67 studies in Macular Degeneration with a site in Korea, Republic of, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Neovascular Age-related Macular Degeneration
04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients aged 50years old or more at the time of consent.
  2. Patients with any history of anti-VEGF treatment(Aflibercept, Bevacizumab, Ranibizumab) for neovascular AMD in the study eye.
  3. Patients who were treated with the last anti-VEGF at least 8 weeks prior to study drug administration.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. Patients who provide written to participate in this clinical study

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Patients who have received any surgery for neovascular AMD.
  3. 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.
  4. Patients with scar, fibrosis, or atrophy involving the center of the fovea in the study eye that might interfere with visual acuity.
  5. Patients with hemorrhage under the fovea or subretinal hemorrhage 50% or more of the total lesion area in the study eye.
  6. Patients with retinal pigment epithelial tears or rips involving the macula in the study eye.
  7. 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.
  8. Patients who have received panretinal photocoagulation in the study eye.
  9. Patients who have received vitreous surgery in the study eye.
  10. Patients with a history of corneal transplant or corneal dystrophy in the study eye.
  11. 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.
  12. Patients who have received trabeculectomy or other filtration surgery in the study eye
  13. Patients with poorly controlled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication) in the study eye.
  14. 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.
  15. 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.
  16. 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.
  17. Patients with aphakia with absence of posterior capsule in the study eye.
  18. Patients who have received therapeutic radiation in the region of the study eye.

  19. Patients who use topical ocular 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:

  20. Patients with any active intraocular or periocular infection or intraocular inflammation in either eye (eg, infectious blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis).
  21. Patients with a history of uveitis in either eye.
  22. Patients with a concurrent or history of scleromalacia in either eye.

  23. 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:

  24. 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.
  25. 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.
  26. Patients with poorly controlled hypertension. (defined as systolic BP is 160 mmHg or more or diastolic BP is 100 mmHg or more despite medication)
  27. Patients with a serious liver, kidney or cardiovascular disorders considered by the principal investigator or investigator.
  28. Patients with a concurrent or history of within 5 years before .
  29. Patients with drug abuse (defined as use of illegal drugs) or alcohol dependence or a history of these conditions.
  30. Patients with a history of drug .
  31. Patients with a history of allergy to aflibercept, fluorescein, indocyanine green and povidone iodine.
  32. Patients with any described in aflibercept package insert.
  33. Females who are pregnant, breastfeeding, or of , unwilling to practice adequate throughout the study.
  34. Patients with type 1 diabetes or increase of (>12%).
  35. Patients who have received any other drug within 12 weeks before screening visit.
  36. Other patients considered by the principal investigator or investigator to be inappropriate as subjects.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    ALT-L9

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

    Biological: ALT-L9

  • Active comparator
    Eylea

    Intravitreal injection of Eylea 50 ul, every 4 weeks

    Biological: Eylea

Interventions

  • BiologicalEylea

    Aflibercept

  • BiologicalALT-L9

    Aflibercept biosimilar

06

What researchers measure

Primary outcomes

  1. Occurrences of adverse events

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

    Time frame: 8 weeks

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, Korea, Republic of
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2020 to primary completion in Dec 2020, 10 months.

Of 60 industry-sponsored phase 1 interventional studies under Macular Degeneration, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 27. This study's 10 months is below that.

Counting every sponsor, half of 75 studies reached it within 18 months; a quarter within 10 and three quarters within 30.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2019
First posted
Aug 15, 2019
StartActual
Feb 5, 2020
Primary completionActual
Dec 22, 2020
CompletionActual
Dec 22, 2020
Last update
Jan 20, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04058535
Lead sponsor
Alteogen, Inc.
Responsible party
Sponsor
First posted
Aug 15, 2019
Start date
Feb 5, 2020
Primary completion
Dec 22, 2020
Completion
Dec 22, 2020
Last update
Jan 20, 2022

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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Alteogen, Inc.

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