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Proliferative Diabetic RetinopathyPhase 3CONDORNCT04278417

Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

A Phase 3 study testing Brolucizumab 6 mg and Panretinal photocoagulation laser in people with Proliferative Diabetic Retinopathy, run by Novartis Pharmaceuticals at 120 sites in 16 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

The purpose of this study was to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR). Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Proliferative Diabetic Retinopathy
What is being tested?
Brolucizumab 6 mg and Panretinal photocoagulation laser
Could I receive a placebo?
No, everyone receives an active treatment
How many people
689 participants
Where
120 sitesin 16 countries
Study dates
19 Nov 2020to 19 Aug 2024
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 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent must be obtained prior to participation
  • Able to complete adequate fundus photographs and retinal images
  • Diagnosis of type 1 or 2 Diabetes Mellitus (DM) and HbA1c less than or equal to 12% at screening
  • DM treatment stable for at least 3 months
  • PDR diagnosis with no previous PRP treatment in the study eye

Who cannot join

  • Concomitant conditions or ocular disorders in the study eye at Screening or Baseline that could compromise a response to study treatment.
  • Presence of diabetic macular edema in the study eye
  • Active infection or inflammation in the study eye
  • Uncontrolled glaucoma (IOP greater than 25 mmHg)
  • Intravitreal anti-VEGF treatment within 6 months
  • Treatment with intraocular corticosteroids
Show all 10Show fewer
  • End stage renal disease requiring dialysis or kidney transplant
  • Uncontrolled blood pressure
  • Systemic anti-VEGF therapy at any time
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

120 sites in 16 countries.

120 sites in 16 countries

United States40 sites

  • Austin Retina Associates

    Austin, Texas, 78705

  • Texan Eye P A

    Austin, Texas, 78731

  • Retina And Vitreous Of Texas

    Bellaire, Texas, 77401

  • Retina Consultants TX Rsrch Ctr

    Bellaire, Texas, 77401

  • Retina- Vitreous Assoc Medical Group

    Beverly Hills, California, 90211

  • Retina Associates Of Cleveland

    Cleveland, Ohio, 44122

  • Advanced Research LLC

    Deerfield Beach, Florida, 33064

  • Rand Eye Institute

    Deerfield Beach, Florida, 33064

  • Retina Associates

    Elmhurst, Illinois, 60126

  • Erie Retinal Surgery

    Erie, Pennsylvania, 16507

  • Pinnacle Research Institute

    Fort Lauderdale, Florida, 33309

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912-7125

  • Texas Retina Associates

    Fort Worth, Texas, 76104

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Valley Retina Institute PA

    Harlingen, Texas, 78550

  • Retina Consultants of Houston PA

    Houston, Texas, 77030

  • Salehi Retina Institute

    Huntington Beach, California, 92647

  • Midwest Eye Institute

    Indianapolis, Indiana, 46280

  • University of Mississippi Med Ctr

    Jackson, Mississippi, 39216

  • Florida Retina Institute

    Jacksonville, Florida, 32216

  • Southeastern Retina Associates P C

    Knoxville, Tennessee, 37923

  • Charleston Neuroscience Institute

    Ladson, South Carolina, 29456

  • Blue Oc Clin Res at Palm Bch Eye Ct

    Lakeland, Florida, 33801

  • Retina Associates PA

    Lenexa, Kansas, 66215

  • MedEye Associates

    Miami, Florida, 33143

  • John-Kenyon American Eye Institute PC

    New Albany, Indiana, 47150

  • Virginia Eye Consultants

    Norfolk, Virginia, 23502

  • Dean McGee Eye Institute

    Oklahoma City, Oklahoma, 73104

  • Florida Retina Institute

    Orlando, Florida, 32804

  • Eye Center of North Florida

    Panama City, Florida, 32405

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324

  • Retina Consultants of Southern California

    Redlands, California, 92374

  • Medical Center Opthamology Assoc

    San Antonio, Texas, 78240

  • Retina Associates Of South Texas PA

    San Antonio, Texas, 78240

  • Cascade Medical Research Institute

    Springfield, Oregon, 97477

  • Premiere Practice Management LLC

    Torrance, California, 90505

  • Lundquist Inst BioMed at Harbor

    Torrance, California, 90509-2910

  • Retina Associates SW

    Tucson, Arizona, 85704

  • Miramar Eye Specialists

    Ventura, California, 93003

Other trials in United States

Japan17 sites

  • Novartis Investigative Site

    Akita, 010-8543

  • Novartis Investigative Site

    Asahikawa, Hokkaido, 078 8510

  • Novartis Investigative Site

    Chiyoda-ku, Tokyo, 101-8309

  • Novartis Investigative Site

    Hachiōji, Tokyo, 193-0944

  • Novartis Investigative Site

    Kita-gun, Kagawa-ken, 761-0793

  • Novartis Investigative Site

    Kobe, 650-0017

  • Novartis Investigative Site

    Kōriyama, Fukushima, 963-8052

  • Novartis Investigative Site

    Kurume, Fukuoka, 830-0011

  • Novartis Investigative Site

    Matsumoto, Nagano, 390-8621

  • Novartis Investigative Site

    Meguro-ku, Tokyo, 152-8902

  • Novartis Investigative Site

    Nagakute, Aichi-ken, 480-1195

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 466 8560

  • Novartis Investigative Site

    Osaka, 545-8586

  • Novartis Investigative Site

    Sakura, Chiba, 285-8741

  • Novartis Investigative Site

    Shimotsuke, Tochigi, 329-0498

  • Novartis Investigative Site

    Tsu, Mie-ken, 514-8507

  • Novartis Investigative Site

    Yoshida-gun, Fukui, 910-1193

Other trials in Japan

China16 sites

  • Novartis Investigative Site

    Beijing, Beijing Municipality, 100044

  • Novartis Investigative Site

    Beijing, 100050

  • Novartis Investigative Site

    Beijing, 100191

  • Novartis Investigative Site

    Beijing, 100730

  • Novartis Investigative Site

    Changchun, Jilin, 130041

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210000

  • Novartis Investigative Site

    Nantong, Jiangsu, 226000

  • Novartis Investigative Site

    Shanghai, 200080

  • Novartis Investigative Site

    Shantou, Guangdong, 515041

  • Novartis Investigative Site

    Shenyang, Liaoning, 110000

  • Novartis Investigative Site

    Tianjin, Tianjin Municipality, 300020

  • Novartis Investigative Site

    Wenzhou, Zhejiang, 325027

  • Novartis Investigative Site

    Wuhan, Hubei, 430060

  • Novartis Investigative Site

    Wuhan, Hubei, 430070

  • Novartis Investigative Site

    Xi'an, Shaanxi, 710004

Other trials in China

Russia8 sites

  • Novartis Investigative Site

    Cheboksary, 428028

  • Novartis Investigative Site

    Moscow, 119021

  • Novartis Investigative Site

    Moscow, 127473

  • Novartis Investigative Site

    Moscow, 127486

  • Novartis Investigative Site

    Omsk, 644024

  • Novartis Investigative Site

    Sterlitamak, 453128

  • Novartis Investigative Site

    Ulyanovsk, 432063

  • Novartis Investigative Site

    Yekaterinburg, 620109

Other trials in Russia

India5 sites

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380 016

  • Novartis Investigative Site

    Chandigarh, 160012

  • Novartis Investigative Site

    Coimbatore, Tamil Nadu, 641014

  • Novartis Investigative Site

    New Delhi, 110 029

  • Novartis Investigative Site

    Tirunelveli, Tamil Nadu, 627003

Other trials in India

Argentina4 sites

  • Novartis Investigative Site

    Caba, Buenos Aires, 1116

  • Novartis Investigative Site

    CABA, C1061AAE

  • Novartis Investigative Site

    Ciudad Autonoma de Bs As, Buenos Aires, C1015ABO

  • Novartis Investigative Site

    Rosario, De Santa Fe, B7602

Other trials in Argentina

Australia4 sites

  • Novartis Investigative Site

    Albury, New South Wales, 2640

  • Novartis Investigative Site

    Liverpool, New South Wales, 2170

  • Novartis Investigative Site

    Parramatta, New South Wales, 2150

  • Novartis Investigative Site

    Strathfield, New South Wales, 2135

Other trials in Australia

Brazil4 sites

  • Novartis Investigative Site

    Blumenau, Santa Catarina, 89052-504

  • Novartis Investigative Site

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Novartis Investigative Site

    São Paulo, São Paulo, 01427-002

  • Novartis Investigative Site

    Sorocaba, São Paulo, 18031-060

Other trials in Brazil

Canada4 sites

  • Novartis Investigative Site

    Boisbriand, Quebec, J7H 1S6

  • Novartis Investigative Site

    Ottawa, Ontario, K2B 7E9

  • Novartis Investigative Site

    Québec, Quebec, G1S 4L8

  • Novartis Investigative Site

    Toronto, Ontario, M5T 2S8

Other trials in Canada

South Korea4 sites

  • Novartis Investigative Site

    Bundang Gu, Gyeonggi-do, 13620

  • Novartis Investigative Site

    Daegu, 705703

  • Novartis Investigative Site

    Seoul, Seocho Gu, 06591

  • Novartis Investigative Site

    Seoul, 06351

Other trials in South Korea

Turkey (Türkiye)4 sites

  • Novartis Investigative Site

    Ankara, 06100

  • Novartis Investigative Site

    Ankara, 06230

  • Novartis Investigative Site

    Istanbul, 34420

  • Novartis Investigative Site

    Izmir, 35340

Other trials in Turkey (Türkiye)

Mexico3 sites

  • Novartis Investigative Site

    Ciudad de, Mexico City, 06800

  • Novartis Investigative Site

    Mexico City, 06760

  • Novartis Investigative Site

    Tijuana, 22010

Other trials in Mexico

Philippines3 sites

  • Novartis Investigative Site

    Makati, NCR, 1229

  • Novartis Investigative Site

    Makati, 1229

  • Novartis Investigative Site

    Pasig, 1605

Other trials in Philippines

Taiwan2 sites

  • Novartis Investigative Site

    Hualien City, 970

  • Novartis Investigative Site

    Kaohsiung City, 80756

Other trials in Taiwan

Chile1 site

  • Novartis Investigative Site

    Santiago, RM, 7560994

Other trials in Chile

Puerto Rico1 site

  • Emanuelli Research and Development Center LLC

    Arecibo, 00612

Other trials in Puerto Rico

About this study

Official title: A 96-week, Two-arm, Randomized, Single-masked, Multi-center, Phase III Study Assessing the Efficacy and Safety of Brolucizumab 6 mg Compared to Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy

The purpose of this study was to evaluate the efficacy and safety of brolucizumab compared to panretinal photocoagulation laser (PRP) in patients with proliferative diabetic retinopathy (PDR). This evaluation will provide information that brolucizumab is non-inferior to PRP with respect to the change in best corrected visual acuity at Week 54.

Read the detailed description

Phase III, 96-week, two-arm, randomized (1:1 ratio), single-masked, multi-center, active-controlled study to evaluate the efficacy and safety of brolucizumab compared to Panretinal photocoagulation (PRP) in subjects with Proliferative diabetic retinopathy (PDR).

Subjects who consented underwent screening assessments to evaluate their eligibility based on the inclusion and exclusion criteria. Subjects who met all the inclusion and none of the exclusion criteria were randomized in a 1:1 ratio to one of the following treatments:

Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks, and revert to q12w if disease worsens. More frequent injection with q6w interval in the maintenance phase could be administered at the discretion of the Investigator if the disease worsens.

PRP: initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment (may split into 2-4 sessions) as needed up to Week 90.

Visits occurred every 6 weeks throughout the study, regardless of treatment or not.

Being tested
Brolucizumab 6 mg, Panretinal photocoagulation laser
Keywords
proliferative diabetic retinophathy, retinal neovascularization, anti-VEGF, brolucizumab, intravitreal injection, panretinal photocoagulation
Medical subject headings
Retinal Neovascularization

What participants receive

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

  • Brolucizumab 6 mgBiological

    Also called RTH258

    3 x q6w loading injections, followed by q12w maintenance through Week 90

  • Panretinal photocoagulation laserProcedure or surgery

    Also called PRP

    initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed

Study groups in NCT04278417
Study groupRoleWhat they receive
Brolucizumab 6 mgExperimentalIntra-vitreal injection. 3 x q6w loading injections, followed by q12w maintenance through Week 90
Receives: Biological: Brolucizumab 6 mg
Panretinal photocoagulation laser ArmActive comparatorInitial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed
Receives: Procedure: Panretinal photocoagulation laser

What is being measured

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

  1. Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 54 for the Study Eye

    BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.

    Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of >= 34 ETDRS letters (Snellen equivalent 20/200) at Screening / Baseline in the study eye were included.

    Min and max possible scores are 0-100 respectively. A higher score represents better functioning.

    Last observation carried forward (LOCF) was used for the imputation of missing values.

    Measured: Baseline, Week 54

Secondary outcomes (12)

  1. Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 54 for the Study Eye

    Proliferative diabetic retinopathy (PDR) is derived from the diabetic retinopathy severity scale (DRSS) as assessed by the central reading center (CRC) using 7-field color fundus photography image. The DRSS on the original score with scores varying from 10 (DR absent) to 85 (very advanced PDR) were then converted into a 12-level scale (Range is from 1 - diabetic retinopathy (DR) absent, to 12- very advanced PDR). (A lower score represents a better outcome.) The event of "No PDR" is then defined as DRSS (12-level scale) < 7.

    Measured: Week 54

  2. Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 96 for the Study Eye

    Proliferative diabetic retinopathy (PDR) is derived from the diabetic retinopathy severity scale (DRSS) as assessed by the central reading center (CRC) using 7-field color fundus photography image. The DRSS on the original score with scores varying from 10 (DR absent) to 85 (very advanced PDR) were then converted into a 12-level scale (Range is from 1 - diabetic retinopathy (DR) absent, to 12- very advanced PDR). (A lower score represents a better outcome.) The event of "No PDR" is then defined as DRSS (12-level scale) < 7.

    Measured: Week 96

  3. Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 54 for the Study Eye

    Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.

    PRP = Panretinal photocoagulation laser

    Measured: Up to Week 54

  4. Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 96 for the Study Eye

    Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center.

    PRP = Panretinal photocoagulation laser

    Measured: Up to Week 96

  5. Area Under the Curve in Change From Baseline in BCVA up to Week 54 and up to Week 96 - for the Study Eye

    BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts.

    Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of >= 34 ETDRS letters (Snellen equivalent 20/200) at Screening / Baseline in the study eye were included.

    Min and max possible scores are 0-100 respectively. A higher score represents better functioning.

    Last observation carried forward (LOCF) was used for the imputation of missing values.

    The AUC in change from Baseline in BCVA up to Week 54 (or Week 96) is referred to as the averaged change from Baseline in BCVA at each visit up to 54 (or Week 96), which was calculated as (BCVA at Week 6 + BCVA at Week 12 + ... + BCVA at Week 54 (or Week 96)) / number of visits with valid BCVA data from Week 6 to Week 54 (or Week 96) - BCVA at Baseline.

    Measured: Baseline, up to Week 54 and up to Week 96

  6. Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥2 Steps Improvement From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96

    Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment".

    A lower score represents better functioning.

    Measured: Baseline, Week 54 and Week 96

  7. Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥2 Steps Worsening From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96

    Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment".

    A lower score represents better functioning.

    Measured: Baseline, Week 54 and Week 96

  8. Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥3 Steps Improvement From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96

    Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment".

    A lower score represents better functioning.

    Measured: Baseline, Week 54 and Week 96

  9. Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥3 Steps Worsening From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96

    Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment".

    A lower score represents better functioning.

    Measured: Baseline, Week 54 and Week 96

  10. Number and Percentage of Subjects Developing Vision-threatening Complications Associated With Diabetic Retinopathy up to Week 54 and up to Week 96

    The vision-threatening complications associated with Diabetic retinopathy (DR) are defined as any event of the following list occurring in the study eye at any time point after Baseline:

    • Center-involved Diabetic macular edema (CI-DME) as defined as Central sub-field thickness (CSFT) ≥280 µm according to Central reading center (CRC) evaluation of Optical coherent tomography (OCT) image
    • Retinal detachment
    • Vitreous hemorrhage
    • Neovascular glaucoma, iris/ anterior chamber angle neovascularization
    • Vitrectomy for DR complications

    Measured: up to Week 54 and up to Week 96

  11. Ocular AEs (>= 2% in Any Treatment Arm) by Preferred Term for the Study Eye

    An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject.

    AEs that started after alternative diabetic retinopathy treatment/relevant diabetic macular edema treatment in the study eye are censored.

    Measured: Adverse events are reported from first dose of study treatment up to Week 90, plus approximately 6 weeks post-treatment, up to a maximum timeframe of approximately 96 weeks.

  12. Non-ocular AEs (≥ 2% in Any Treatment Arm) by Preferred Term

    An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject.

    AEs that started after alternative diabetic retinopathy treatment/relevant diabetic macular edema treatment in the study eye are censored.

    Measured: Adverse events are reported from first dose of study treatment up to Week 90, plus approximately 6 weeks post-treatment, up to a maximum timeframe of approximately 96 weeks.

Timeline

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

  1. First posted20 Feb 2020
  2. Study start19 Nov 2020
  3. Primary completion30 Oct 2023
  4. Study completion19 Aug 2024

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
Single blind
Who is masked
Outcomes assessor
Enrolment
689 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04278417
Sponsor's protocol ID
CRTH258D2301
Acronym
CONDOR
Status last verified
Oct 2025
First submitted
18 Feb 2020
Last updated
16 Oct 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

Publications

  • Wolf S, Chen Y, Li X, Shimura M, Sakamoto T, Wykoff CC, Emanuelli A, Salehi-Had H, Yan K, Kovacic L, Kim Y. Brolucizumab in the Treatment of Proliferative Diabetic Retinopathy: The CONDOR Randomized Clinical Trial. JAMA Ophthalmol. 2026 Jun 1;144(6):500-507. doi: 10.1001/jamaophthalmol.2026.1008.

    PubMed 42024409

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Brolucizumab 6 mg and Panretinal photocoagulation laser in people with Proliferative Diabetic Retinopathy, run by Novartis Pharmaceuticals at 120 sites in 16 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 10 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 16 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 120 sites in United States, Japan, China, Russia, India and 11 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 20 Aug 2024). 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 Best-corrected Visual Acuity (BCVA) at Week 54 for the Study Eye (time frame: Baseline, Week 54). 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 NCT04278417, which also lists 1 linked publication.

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 16 Oct 2025.

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