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Wet Age-related Macular DegenerationPhase 3NCT04480463

A Study to Comparing SCD411 and Eylea® in Subjects With Wet Age-related Macular Degeneration (AMD)

A Phase 3 study testing SCD411 and Aflibercept in people with Wet Age-related Macular Degeneration and Neovascular Age-related Macular Degeneration, run by Sam Chun Dang Pharm. Co. Ltd. at 130 sites in 14 countries.

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

Age-related macular degeneration (AMD) is a leading cause of vision loss in adults. Abnormal blood vessels grow under the macula at the back of the eye, and also leak blood and fluid, which damages and scars the macula, affecting vision. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
SCD411 and Aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
576 participants
Where
130 sitesin 14 countries
Study dates
13 Aug 2020to 8 Sep 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Provides written informed consent.
  • Clinical diagnosis of wet (neovascular) age-related macular degeneration (AMD).
  • BCVA (best corrected visual acuity) letter score of 73 to 35 at screening and prior to randomization. In addition, fellow eye should not be less than 35 letter score using the ETDRS chart or 2702 series number chart.
  • Women of child-bearing potential with negative serum pregnancy test at screening must agree to use protocol-defined methods of contraception throughout study until 3 months after last injection of aflibercept/SCD411.
  • Males with female partners of child-bearing potential must agree to use protocol-defined methods of contraception and refrain from donating sperm throughout study until 3 months after last injection of aflibercept/SCD411.

Who cannot join

  • Any prior eye (study eye and fellow eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins.
  • Any prior or current treatment with another investigational agent to great neovascular AMD in the study eye, except dietary supplements or vitamins.
  • Fellow eye shows signed of AMD that may need treatment during study period.
  • Any prior treatment with anti-VEGF agents in both eyes.
  • Total lesion size >30.5 mm2, Blood, scars, atrophy, fibrosis, and neovascularization, based on assessment at screening.
  • Central retina thickness of <300 µm in the study eye.
Show all 30Show fewer
  • Subretinal hemorrhage that is either 50% or more of the total lesion area.
  • Scar or fibrosis making up >50% of the total lesion.
  • Scar, fibrosis, or atrophy involving the center of the fovea in the study eye.
  • Presence of retinal pigment epithelial tears or rips involving the macular in the study eye.
  • Cataract in the study eye that have Lens Opacity Classification System II (LOCS II) grade IV cataract in the study eye or in the Investigator's opinion, interferes with visualization of retina or retinal imaging.
  • Inflammation outside the eyeball in either eye, or within the eyeball of the study eye.
  • History of any vitreous hemorrhage in the study eye.
  • History or clinical evidence of diabetic retinopathy, diabetic macular edema, or any other vascular disease.
  • History of, treatment or surgery for detached retina.
  • History of uncomplicated surgery within the eyeball or around the study eye, except lid surgery.
  • Absence of lens in study eye.
  • Uncontrolled hypertension, defined as systolic blood pressure (BP) >160 mmHg or diastolic BP >100 mmHg under appropriate antihypertensive treatment.
  • Hypersensitivity to aflibercept or medications used in the study (fluorescein, mydriatic eye drops, etc.).
  • Pregnancy or lactation at Screening or at baseline for women of child-bearing potential.
  • History of blood clotting events.
  • History or evidence of cardiac conditions, or inability to perform any physical activity without discomfort; ventricular arrhythmia; and atrial fibrillation.
  • History of laser therapy in the macular region.
  • Any prior or current treatment with corticosteroids inside or immediately around the study eye.
  • Any prior or current treatment involving the macula with photodynamic therapy (PDT) with verteporfin, transpupillary thermotherapy, radiation therapy, or retinal laser treatment in the study eye.
  • Any prior or current treatment with pan-retinal photocoagulation.
  • Any prior or current treatment with ethambutol; deferoxamine and topiramate; tamoxifen, hydroxychloroquine, chloroquine, or vigabatrin; and amiodarone.
  • Any investigational product for the treatment of eye conditions and systemic conditions, 30 days or 5 half-lives (whichever is longer), prior to randomization, and throughout the study, except dietary supplements or vitamins.
  • Intraocular pressure ≥25 mmHg in spite of anti-glaucoma treatment.
  • Any prior or ongoing systemic medical condition (including but not limited to infectious, inflammatory, psychiatric, neurological, renal, hepatic, respiratory conditions or malignancies) or clinically significant screening laboratory value that in the opinion of the investigator may present a safety risk, interfere with study compliance and follow-up, or confound data interpretation throughout the study period.

Trial locations and contacts

130 sites in 14 countries.

130 sites in 14 countries

South Korea26 sites

  • SCD Research Site

    Busan, 48108

  • SCD Research Site

    Busan, 49201

  • SCD Research Site

    Busan, 49241

  • SCD Research Site

    Busan, 49267

  • SCD Research Site

    Changwon-Si, Gyeongsangnam-do, 51472

  • SCD Research Site

    Cheongju-si, North Chungcheong, 28644

  • SCD Research Site

    Daegu, 41944

  • SCD Research Site

    Daegu, 42415

  • SCD Research Site

    Daegu, 42601

  • SCD Research Site

    Daejeon, 35015

  • SCD Research Site

    Daejeon, 35365

  • SCD Research Site

    Guri-si, Gyeonggido, 11923

  • SCD Research Site

    Gwangju, 61469

  • SCD Research Site

    Incheon, 21565

  • SCD Research Site

    Incheon, 22332

  • SCD Research Site

    Jinju, 52727

  • SCD Research Site

    Seoul, 02447

  • SCD Research Site

    Seoul, 02841

  • SCD Research Site

    Seoul, 03080

  • SCD Research Site

    Seoul, 05355

  • SCD Research Site

    Seoul, 05505

  • SCD Research Site

    Seoul, 06198

  • SCD Research Site

    Seoul, 06351

  • SCD Research Site

    Seoul, 07441

  • SCD Research Site

    Seoul, 7061

  • SCD Research Site

    Suwon, Gyeonggido, 16499

Other trials in South Korea

Japan22 sites

  • SCD Research Site

    Amagasaki, Hyôgo, 660-8550

  • SCD Research Site

    Chuo Ku, Tokyo, 104-8560

  • SCD Research Site

    Fukuoka, 812-0011

  • SCD Research Site

    Fukushima, 960-1295

  • SCD Research Site

    Hachiōji, Tokyo, 193-0998

  • SCD Research Site

    Kagoshima, Kagoshima-ken, 890-8520

  • SCD Research Site

    Kita-ku, 761-0793

  • SCD Research Site

    Kobe, Hyōgo, 650-0047

  • SCD Research Site

    Kurume, Hukuoka, 830-0011

  • SCD Research Site

    Kyoto, Kyôto, 607-8062

  • SCD Research Site

    Meguro City, Tokyo, 152-8902

  • SCD Research Site

    Nagakute, 480-1195

  • SCD Research Site

    Nagoya, Aiti, 457-8510

  • SCD Research Site

    Nakagami, Okinawa, 903-0215

  • SCD Research Site

    Nerima-ku, Tokyo, 177-8521

  • SCD Research Site

    Niigata, 951-8520

  • SCD Research Site

    Nishinomiya, Hyōgo, 663-8501

  • SCD Research Site

    Saga, 849-8501

  • SCD Research Site

    Sakai, 593-8304

  • SCD Research Site

    Sakura, 285-8741

  • SCD Research Site

    Toyama, 930-0194

  • SCD Research Site

    Ube, Yamaguchi, 755-8505

Other trials in Japan

Poland14 sites

  • SCD Research Site

    Bydgoszcz, 85-631

  • SCD Research Site

    Bydgoszcz, 85-870

  • SCD Research Site

    Gdansk, Pomeranian Voivodeship, 80-809

  • SCD Research Site

    Katowice, Silesian Voivodeship, 40-514

  • SCD Research Site

    Katowice, Silesian Voivodeship, 40-594

  • SCD Research Site

    Lublin, 20-079

  • SCD Research Site

    Olsztyn, Warminsko-marzurskie, 10-424

  • SCD Research Site

    Rzeszów, Podkarpackie Voivodeship, 35-017

  • SCD Research Site

    Wałbrzych, Lower Silesian Voivodeship, 58-309

  • SCD Research Site

    Warsaw, Masovian Voivodeship, 01-258

  • SCD Research Site

    Warsaw, Masovian Voivodeship, 01-364

  • SCD Research Site

    Warsaw, 00-215

  • SCD Research Site

    Wroclaw, Lower Silesian Voivodeship, 50-556

  • SCD Research Site

    Wroclaw, Lower Silesian Voivodeship, 50-981

Other trials in Poland

United States12 sites

  • SCD Research Site

    Abilene, Texas, 79606

  • SCD Research Site

    Campbell, California, 95008

  • SCD Research Site

    Clearwater, Florida, 33761

  • SCD Research Site

    Coral Springs, Florida, 33067

  • SCD Research Site

    Fort Myers, Florida, 33912

  • SCD Research Site

    Lemont, Illinois, 60439

  • SCD Research Site

    Liverpool, New York, 13088

  • SCD Research Site

    Marietta, Georgia, 30060

  • SCD Research Site

    Rapid City, South Dakota, 57701

  • SCD Research Site

    Springfield, Oregon, 97477

  • SCD Research Site

    Stuart, Florida, 34994

  • SCD Research Site

    Willow Park, Texas, 76087

Other trials in United States

Israel12 sites

  • SCD Research Site

    Haifa, 31096

  • SCD Research Site

    Haifa, 34362

  • SCD Research Site

    Holon, 58100

  • SCD Research Site

    Jerusalem, 91120

  • SCD Research Site

    Kfar Saba, 44281

  • SCD Research Site

    Nahariya, 22100

  • SCD Research Site

    Petah Tikva, 49100

  • SCD Research Site

    Ramat Gan, 52621

  • SCD Research Site

    Rehovot, 76100

  • SCD Research Site

    Tel Aviv, 64239

  • SCD Research Site

    Tiberias, 15208

  • SCD Research Site

    Tsrifin, 70300

Other trials in Israel

Spain9 sites

  • SCD Research Site

    Barcelona, 08022

  • SCD Research Site

    Barcelona, 08025

  • SCD Research Site

    Bilbao, 48006

  • SCD Research Site

    Bilbao, 48010

  • SCD Research Site

    Majadahonda, 28222

  • SCD Research Site

    Sant Cugat del Vallès, Barcelona, 08195

  • SCD Research Site

    Valencia, 46014

  • SCD Research Site

    Valladolid, 47012

  • SCD Research Site

    Zaragoza, 50009

Other trials in Spain

Hungary7 sites

  • SCD Research Site

    Budapest, 1062

  • SCD Research Site

    Budapest, 1085

  • SCD Research Site

    Budapest, 1133

  • SCD Research Site

    Budapest, 1204

  • SCD Research Site

    Debrecen, 4032

  • SCD Research Site

    Nyíregyháza, 4400

  • SCD Research Site

    Pécs, 7621

Other trials in Hungary

India7 sites

  • SCD Research Site

    Bhubaneswar, Odisha, 751024

  • SCD Research Site

    Hyderabad, Telangana, 500018

  • SCD Research Site

    Jaipur, Rajasthan, 302015

  • SCD Research Site

    Kolkata, West Bengal, 700020

  • SCD Research Site

    Kolkata, West Bengal, 700073

  • SCD Research Site

    Lucknow, Uttar Pradesh, 226001

  • SCD Research Site

    Wardha, Maharashtra, 442001

Other trials in India

Australia4 sites

  • SCD Research Site

    East Melbourne, Victoria, 3002

  • SCD Research Site

    Liverpool, New South Wales, 2170

  • SCD Research Site

    Nedlands, Western Australia, 6009

  • SCD Research Site

    Sydney, New South Wales, 2000

Other trials in Australia

Latvia4 sites

  • SCD Research Site

    Jelgava, LV-3001

  • SCD Research Site

    Riga, LV-1002

  • SCD Research Site

    Riga, LV-1006

  • SCD Research Site

    Riga, LV-1009

Other trials in Latvia

Russia4 sites

  • SCD Research Site

    Moscow, 101750

  • SCD Research Site

    Moscow, 127473

  • SCD Research Site

    Moscow, 127486

  • SCD Research Site

    Novosibirsk, 630087

Other trials in Russia

Slovakia4 sites

  • SCD Research Site

    Bratislava, 826 06

  • SCD Research Site

    Poprad, 058 45

  • SCD Research Site

    Trebišov, 075 01

  • SCD Research Site

    Žilina, 012 07

Other trials in Slovakia

Bulgaria3 sites

  • SCD Research Site

    Sofia, Sofia-Grad, 1431

  • SCD Research Site

    Sofia, Sofia-Grad, 1784

  • SCD Research Site

    Sofia, 1618

Other trials in Bulgaria

Czechia2 sites

  • SCD Research Site

    Pardubice, Pardubice Region, 530 02

  • SCD Research Site

    Prague, 128 08

Other trials in Czechia

About this study

Official title: A Phase III Randomized, Double-Masked, Parallel Group, Multicenter Study to Compare the Efficacy, Safety, Tolerability, Pharmacokinetics, and Immunogenicity Between SCD411 and Eylea® in Subjects With Neovascular Age-related Macular Degeneration

Age-related macular degeneration (AMD) is a leading cause of vision loss in adults. Abnormal blood vessels grow under the macula at the back of the eye, and also leak blood and fluid, which damages and scars the macula, affecting vision. The current standard of care for patients with neovascular (exudative / wet) AMD is anti-vascular endothelial growth factor (anti-VEGF) therapy, which prevents or slows down the growth of the abnormal blood vessels. SCD411 is being developed as a biosimilar to the reference product Eylea® (aflibercept), an anti-VEGF drug. The study aims to prove equivalence of SCD411 to Eylea in adults with wet AMD, and will look at safety, tolerance, effectiveness, immune response and the movement of the drug through the body.

Being tested
SCD411, Aflibercept
Keywords
Age-related macular degeneration, AMD, Neovascular, Exudative
Medical subject headings
Macular Degeneration

What participants receive

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

  • SCD411Drug

    IVT (intravitreal) injection

  • AfliberceptDrug

    Also called Eylea®

    IVT injection

Study groups in NCT04480463
Study groupRoleWhat they receive
SCD411ExperimentalNot described
Receives: Drug: SCD411
AfliberceptActive comparatorNot described
Receives: Drug: Aflibercept

What is being measured

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

  1. Change From Baseline in BCVA (Best Corrected Visual Acuity)

    Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts

    Measured: Baseline to Week 8

Secondary outcomes (2)

  1. Change From Baseline in BCVA (Best Corrected Visual Acuity)

    Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score or 2702 charts

    Measured: Baseline to Week 52

  2. Percentage of Subjects With Anti-SCD411 Antibodies

    Assessed by blood samples

    Measured: Baseline, Weeks 4, 8, 20, 36 and 52

Timeline

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

  1. First posted21 Jul 2020
  2. Study start13 Aug 2020
  3. Primary completion8 Sep 2022
  4. Study completion8 Sep 2022

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
576 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04480463
Sponsor's protocol ID
SCD411-CP101
Other IDs
2019-004132-37, 2019
Status last verified
Oct 2023
First submitted
17 Jul 2020
Last updated
10 Oct 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SCD411 and Aflibercept in people with Wet Age-related Macular Degeneration and Neovascular Age-related Macular Degeneration, run by Sam Chun Dang Pharm. Co. Ltd. at 130 sites in 14 countries.

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 5 inclusion and 30 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 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 130 sites in South Korea, Japan, Poland, United States, Israel and 9 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change From Baseline in BCVA (Best Corrected Visual Acuity) (time frame: Baseline to Week 8). 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 NCT04480463.

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 10 Oct 2023.

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