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Age-Related Macular DegenerationPhase 2NCT03725501

Evaluation of the Safety and Efficacy of ALS-L1023 Administered in Combination With Ranibizumab in Patients With Wet-AMD

A Phase 2 study testing ALS-L1023 and Ranibizumab in people with Age-Related Macular Degeneration, run by AngioLab, 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
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Trial summary

The objective of this phase 2 study is to determine the optimal dose of ALS-L1023 by evaluating the safety and efficacy of ALS-L1023 comparing with placebo when used in combination with Ranibizumab for the treatment of wet age-related macular degeneration(AMD). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age-Related Macular Degeneration
What is being tested?
ALS-L1023 and Ranibizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
126 participants
Where
1 siteSouth Korea
Study dates
7 Dec 2018to 22 Jun 2021
Phase
Phase 2
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

  • Subjects aged 50 years or older;
  • Subjects who can give a written informed consent;
  • Subjects who have active, subfoveal choroidal neovascularization(CNV) Active indicates the confirmation of fluorescence leakage by FAG and the presence of intraretinal or subretinal fluid by optical coherence tomography(OCT);
  • Subjects whose area of fibrosis is less than 50% of total lesion area;
  • Subjects with BCVA letter score of 73-24 (20/40 to 20/320 Snellen Equivalent) using ETDRS chart measured at 4 meters distance;
  • Subjects who have a maximum lesion size of 12 optic-disk areas (1 optic-disk area equals 2.54 mm2 on the basis of 1 optic-disk diameter of 1.8 mm) with neovascularization.

Who cannot join

  • Subjects who have any prior ocular or systematic treatment or surgery in the study eye for neovascular AMD like Photodynamic therapy(PDT), laser photocoagulation etc. except dietary supplements or vitamins;
  • Subjects who received any prior or concomitant therapy in the study eye with anti-VEGF therapy (for example Ranibizumab, Bevacizumab, Aflibercept etc.). This does not apply to treatment of the opposite eye;
  • Subjects whose total lesion size is ≥12 disc areas (30.5 mm2), including blood, scars, and neovascularization) as assessed by Fluorescein angiography(FAG) in the study eye;
  • Subjects who have sub-retinal hemorrhage that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea, then the fovea must be surrounded 270° by visible CNV);
  • Subjects who have scar or fibrosis making up >50% of the total lesion in the study eye;
  • Subjects who have scar, fibrosis, or atrophy involving the center of the fovea in the study eye;
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  • Subjects who have presence of retinal pigment epithelial tears or rips involving the macula in the study eye;
  • Subjects with a history of any vitreous hemorrhage within 4 weeks prior to Screening in the study eye;
  • Subjects who have presence of other causes of CNV in the study eye;
  • Subjects who had prior vitrectomy in the study eye;
  • Subjects with a history of retinal detachment or treatment or surgery for retinal detachment in the study eye;
  • Subjects with any history of macular hole of stage 2 and above in the study eye;
  • Subjects who have any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1, as long as it is unlikely to interfere with the injection;
  • Subjects diagnosed with diabetes who have diabetic retinopathy or HbA1c value of 8 or more at screening;
  • Subjects with a history or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye;
  • Subjects who have macular disease or media opacity (including cataracts and vitreous opacity) that can be affect vision at the time of AMD diagnosis according to investigator' discretion;
  • Subjects who have hypersensitivity to investigational products or to drugs with similar chemical structures;
  • Subjects with infections/suspected infections in or around the eye;
  • Subjects who have severe intraocular inflammation;
  • Female subjects who are pregnant or breastfeeding;
  • Female subjects of childbearing age but are not using one or more of the following contraceptive methods:
  • Surgically sterile (i.e. have had bilateral tubal ligation or vasectomy)
  • Hormonal contraceptives (implant, patch, or oral)
  • Double barrier contraception (must use two of the following: intrauterine device, male or female condoms with spermicide, diaphragm, contraceptive sponge, cervical cap)
  • Periodic abstinence (i.e. calendar rhythm method, Billings Ovulation Method, and basal body temperature) and withdrawal method are not considered as appropriate contraceptive methods, and subjects must continue to use effective methods of contraception throughout the study and for 30 days after the end of the study;
  • Subjects who experienced cardiovascular or cerebrovascular events within 12 months prior to Screening;
  • Subjects who have any clinically significant medical condition that would interfere with the study outcomes or subjects who are deemed inappropriate to participate in the study according to Investigator's discretion.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • AngioLab, Inc.

    Daejeon, Daejeon Gwangyeogsi, 34015

Other trials in South Korea

About this study

Official title: A Phase 2, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Three-arm Parallel-Group, 12-Month Study to Evaluate the Safety and Efficacy of ALS-L1023 Administered in Combination With Ranibizumab in Patients With Wet-AMD

The objective of this phase 2 study is to determine the optimal dose of ALS-L1023 by evaluating the safety and efficacy of ALS-L1023 comparing with placebo when used in combination with Ranibizumab for the treatment of wet age-related macular degeneration(AMD).

The study is designed as multicenter, randomized, placebo-controlled, double-blind, three-arm parallel-group phase 2 study in patients with neovascular age-related macular degeneration.

Read more

This study consists of two separate phases: a loading phase and a PRN(pro re nata) phase.

Once the subject provides a written informed consent, subject information including demographics, medical history, and concomitant medications will be collected, and only those who meet the inclusion/exclusion criteria will participate in the study.

All subjects who are enrolled in the study will be randomized into three groups Group A (Ranibizumab 0.5mg \& ALS-L1023 600mg) or Group B (Ranibizumab 0.5mg \& ALS-L1023 1200mg) or Group C (Ranibizumab \& placebo) in a 1:1:1 ratio. Randomization will be stratified by whether or not the subject has PCV(polypoidal choroidal vasculopathy) confirmed at Screening test.

During the 3-month loading phase, all subjects will receive a Ranibizumab 0.5mg injection into the vitreous every month and take either the placebo or ALS-L1023 orally twice a day. During the following 3-12 month PRN phase, subjects will continue to take the placebo or ALS-L1023 in the same frequency as above but receive Ranibizumab injection only when it meets retreatment criteria. Subjects must instill antibacterial eye drops three times a day for three days after Ranibizumab injection.

Subjects will visit the study site monthly during the 12 month study period in order to receive scheduled assessments and evaluate safety and efficacy of treatment. Image interpretation will be performed by a central reading center. The central reading center will confirm eligibility for enrollment and the discrimination of Polypoidal Choroidal Vasculopathy(PCV) at screening and play a role in interpreting whole images of all subjects after the end of the study.

Being tested
ALS-L1023, Ranibizumab, Placebo
Medical subject headings
Macular Degeneration

What participants receive

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

  • ALS-L1023Drug

    Also called McEye

    ALS-L1023 is an active fraction extracted from Melissa officinalis L. (Labiatae; lemon balm) leaves.

  • RanibizumabDrug

    Also called Lucentis

    LUCENTIS® (an anti-neovascular VEGF-A inhibitor) 0.5 mg, intravitreal injection

  • PlaceboOther

    Control group for comparison with oral administration of ALS-L1023

Study groups in NCT03725501
Study groupRoleWhat they receive
Ranibizumab + ALS-L1023 600mgExperimental* ALS-L1023 600 mg - Take 2 tablets orally twice a day. * Ranibizumab (Lucentis®) * Loading Phase (3 months): Intravitreally inject 0.5 mg of Ranibizumab/0.05 mL monthly. * PRN Phase (9 months): It should only be administered to subjects who meet the re-administered criteria.
Receives: Drug: ALS-L1023; Drug: Ranibizumab
Ranibizumab + ALS-L1023 1200mgExperimental* ALS-L1023 1200 mg - Take 2 tablets orally twice a day. * Ranibizumab (Lucentis®) * Loading Phase (3 months): Intravitreally inject 0.5 mg of Ranibizumab/0.05 mL monthly. * PRN Phase (9 months): It should only be administered to subjects who meet the re-administered criteria.
Receives: Drug: ALS-L1023; Drug: Ranibizumab
Ranibizumab + PlaceboPlacebo comparator* Placebo - Take 2 tablets orally twice a day. * Ranibizumab (Lucentis®) * Loading Phase (3 months): Intravitreally inject 0.5 mg of Ranibizumab/0.05 mL monthly. * PRN Phase (9 months): It should only be administered to subjects who meet the re-administered criteria.
Receives: Drug: Ranibizumab; Other: Placebo

What is being measured

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

  1. Mean change of Best Corrected Visual Acuity(BCVA).

    Mean change of BCVA(Best Corrected Visual Acuity) as assessed by ETDRS(Early Treatment Diabetic Retinopathy Study) chart at a distance of 4 meters at month 12 compared with baseline.

    Measured: 12 months

Secondary outcomes (2)

  1. Mean change in BCVA(at each visit)

    Mean change in BCVA as assessed by ETDRS chart at a distance of 4 meters at each visit except month 12 compared with baseline.

    Measured: 12 months

  2. Mean number of Ranibizumab re-administration

    Mean number of Ranibizumab re-administration after Ranibizumab loading dose.

    Measured: 12 months

Timeline

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

  1. First posted31 Oct 2018
  2. Study start7 Dec 2018
  3. Primary completion22 Jun 2021
  4. Study completion22 Jun 2021

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
126 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03725501
Sponsor's protocol ID
ALS-L1023_AMD_201
Status last verified
Aug 2022
First submitted
2 Oct 2018
Last updated
11 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ALS-L1023 and Ranibizumab in people with Age-Related Macular Degeneration, run by AngioLab, 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 6 inclusion and 27 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 11 Aug 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Mean change of Best Corrected Visual Acuity(BCVA). (time frame: 12 months). 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 NCT03725501.

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 11 Aug 2022.

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