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Macular EdemaPhase 3BEACONNCT04592419

A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)

A Phase 3 study testing KSI-301 and Aflibercept in people with Macular Edema and Retinal Vein Occlusion, run by Kodiak Sciences Inc at 141 sites in 12 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

This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Macular Edema, Retinal Vein Occlusion
What is being tested?
KSI-301 and Aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
568 participants
Where
141 sitesin 12 countries
Study dates
25 Sep 2020to 19 Jan 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent prior to participation in the study.
  • Treatment-naïve macular edema of 6 months duration or less due to CRVO or BRVO. Participants with hemiretinal vein occlusion will be included as CRVO.
  • BCVA ETDRS letter score between 80 and 25 (20/25 to 20/320 Snellen equivalent), inclusive in the Study Eye.
  • CST of ≥ 320 microns on SD-OCT (Heidelberg Spectralis or equivalent on other OCT instruments) as determined by the Reading Center
  • Decrease in vision determined by the Investigator to be primarily the result of ME secondary to RVO.
  • Other protocol-specified inclusion criteria may apply.

Who cannot join

  • Macular edema in the Study Eye for reasons other than RVO
  • Active iris or angle neovascularization, neovascular glaucoma, neovascularization of the optic disc, retinal neovascularization or vitreous hemorrhage in the Study Eye.
  • Uncontrolled glaucoma in the Study Eye.
  • Active retinal disease other than the condition under investigation in the Study Eye.
  • Any history or evidence of a concurrent ocular condition present, that in the opinion of the Investigator could require either medical or surgical intervention alter visual acuity during the study
  • Active or suspected ocular or periocular infection or inflammation
Show all 12Show fewer
  • Any prior use of an approved or investigational treatment for macular edema secondary to RVO in the Study Eye (e.g. anti-VEGF, intraocular or periocular steroids, macular laser photocoagulation).
  • Women who are pregnant or lactating or intending to become pregnant during the study.
  • Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥100 mmHg while at rest
  • Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event.
  • History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.
  • Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

141 sites in 12 countries.

141 sites in 12 countries

United States81 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Florida Eye Clinic

    Altamonte Springs, Florida, 32701

  • Asheville Eye Associates

    Asheville, North Carolina, 28803

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Research Center for Retina

    Austin, Texas, 78705

  • Austin Retina Associates

    Austin, Texas, 78705

  • Retina Research Center

    Austin, Texas, 78705

  • Retina Associates of Cleveland

    Beachwood, Ohio, 44122

  • Retina Research of Beaufort

    Beaufort, South Carolina, 29902

  • Retina Vitreous Associates

    Beverly Hills, California, 90211

  • The Retina Center of New Jersey

    Bloomfield, New Jersey, 07017

  • Retina Group of Florida

    Boca Raton, Florida, 33431

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Florida Eye Microsurgical Institute

    Boynton Beach, Florida, 33426

  • Charlotte Eye Ear Nose & Throat Associates, P.A.

    Charlotte, North Carolina, 28210

  • Retina Group of Washington

    Chevy Chase, Maryland, 20815

  • The Macula Center/ Blue Ocean Clinical Research

    Clearwater, Florida, 33761

  • Retina Associates of Cleveland

    Cleveland, Ohio, 44130

  • Conneticut Eye Consultants

    Danbury, Connecticut, 06810

  • Rand Eye Institute

    Deerfield Beach, Florida, 33064

  • Vitreoretinal Surgery PA

    Edina, Minnesota, 55435

  • Talley Eye

    Evansville, Indiana, 47710

  • National Ophthalmic Research Institute

    Fort Myers, Florida, 33912

  • Eye Medical Center of Fresno

    Fresno, California, 93720

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Vitreo Retinal Associates

    Gainesville, Florida, 32607

  • Charles Retina Institute

    Germantown, Tennessee, 38138

  • Foundation for Vision Research

    Grand Rapids, Michigan, 49525

  • Retina Consultants of Carolina

    Greenville, South Carolina, 29605

  • Cumberland Valley Retina Consultants PC

    Hagerstown, Maryland, 21740

  • Vitreo Retinal Consultants

    Hauppauge, New York, 11788

  • Retina Consultants of NV

    Henderson, Nevada, 89052

  • Retina Consultants of Texas

    Houston, Texas, 77030

  • Retina Consultants of Texas - (Katy)

    Katy, Texas, 77494

  • Southeastern Retina Associates PC

    Knoxville, Tennessee, 37909

  • UCSD Jacobs Retina Center

    La Jolla, California, 92037

  • Charleston Neuroscience Institute

    Ladson, South Carolina, 29456

  • Colorado Retina Associates PC

    Lakewood, Colorado, 80228

  • Retina Associates PA

    Lenexa, Kansas, 66215

  • Retina Associates of Kentucky

    Lexington, Kentucky, 40509

  • Retina-Vitreous Surgeons of Central NY

    Liverpool, New York, 13088

  • Florida Eye Associates

    Melbourne, Florida, 32901

  • Northern California Retina Vitreous Associates

    Mountain View, California, 94040

  • Tennessee Retina PC

    Nashville, Tennessee, 37203

  • Ocli Vision

    Oceanside, New York, 11572

  • Florida Retina Institute

    Orlando, Florida, 32806

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Northwest Arkansas Retina Associates

    Phoenix, Arizona, 85014

  • Retinal Research Institute, LLC

    Phoenix, Arizona, 85014

  • Texas Retina Associates

    Plano, Texas, 75075

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324

  • Maine Eye Center

    Portland, Maine, 04102

  • Retina Northwest

    Portland, Oregon, 97210

  • Retina Consultants of San Diego

    Poway, California, 92064

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701

  • Retina Consultants of Southern California

    Redlands, California, 92374

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retina Institute of Virginia

    Richmond, Virginia, 23235

  • Retina Associates of Western NY

    Rochester, New York, 14620

  • Austin Retina Associates (Round Rock)

    Round Rock, Texas, 78681

  • Associated Retinal Consultants PC

    Royal Oak, Michigan, 78073

  • Retinal Consultants Medical Group Inc

    Sacramento, California, 95819

  • Retina Consultants, LLC

    Salem, Oregon, 97302

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • Orange County Retina Medical Group

    Santa Ana, California, 92705

  • California Retina Consultants

    Santa Maria, California, 93454

  • Retina Center Northwest

    Silverdale, Washington, 98383

  • Spokane Eye

    Spokane, Washington, 99204

  • Springfield Clinic LLP

    Springfield, Illinois, 62703

  • Cascade Medical Research Institute

    Springfield, Oregon, 97477

  • Southern Vitreoretinal Associates

    Tallahassee, Florida, 32308

  • Retina Associates of Florida

    Tampa, Florida, 33609

  • NJ Retina

    Teaneck, New Jersey, 07605

  • Retina Consultants of Texas - (Woodlands)

    The Woodlands, Texas, 77384

  • Retina Group of New England

    Waterford, Connecticut, 06385

  • Pametto Retina Center

    West Columbia, South Carolina, 29501

  • Wolfe Eye Clinic

    West Des Moines, Iowa, 50266

  • Vitreo Retinal Consultants and Surgeons

    Wichita, Kansas, 67214

  • Strategic Clinical Research Group, LLC

    Willow Park, Texas, 76087

  • Center for Retina & Macular Disease

    Winter Haven, Florida, 33880

  • Vitreo Retinal Associates PC

    Worcester, Massachusetts, 01603

Other trials in United States

Spain10 sites

  • Hospital dos de Maig

    Barcelona, 08025

  • Hospital Clinic de Barcelona

    Barcelona, 08028

  • Instituto Clinico Quirurgico de Oftalmologia

    Bilbao, 48010

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Universitari General de Catalunya - Grupo Quironsalud

    Sant Cugat del Vallès, Barcelona, 08195

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

  • Hospital Universitario Rio Hortega

    Valladolid, 47012

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Israel9 sites

  • Bnai Zion

    Haifa, 31048

  • Rambam MC

    Haifa, 31096

  • Hadassah University Hospital

    Jerusalem, 91120

  • Meir MC

    Kfar Saba, 44281

  • Rabin Medical Center

    Petah Tikva, 49100

  • Kaplan MC

    Rehovot, 76100

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

  • Assuta HaShalom

    Tel Aviv, 6789140

  • Shamir Medical Center Assaf Harofeh

    Tzrifin, 70300

Other trials in Israel

France8 sites

  • Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

    Bordeaux, Gironde, 33076

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94000

  • CHRU Dijon Complexe Du Bocage

    Dijon, Côte-d'Or, 21079

  • Hôpital de La Croix Rousse

    Lyon, Rhône, 69317

  • Centre Paradis Monticelli

    Marseille, 13008

  • Hôpital Lariboisière - Service Pharmacie

    Paris, 75 010

  • Fondation Rothschild

    Paris, 75019

  • CHRU de Poitiers La Miletrie

    Poitiers, 86021

Other trials in France

Poland6 sites

  • Oftalmika Sp. z o.o.

    Bydgoszcz, 85-631

  • Optimum Profesorskie Centrum Okulistyki

    Gdansk, Pomeranian Voivodeship, 80-809

  • Uniwersyteckie Centrum Kliniczne Im. Prof. K. Gibinskiego Slaskiego Uniwersytetu Medycznego w Katowi

    Katowice, Silesian Voivodeship, 40-514

  • Gabinet Okulistyczny Prof. Edward Wylegala

    Katowice, Silesian Voivodeship, 40-594

  • Dr Nowosielska Okulistyka i Chirurgia Oka

    Warsaw, 01-249

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu

    Wroclaw, 50-556

Other trials in Poland

Hungary5 sites

  • MH EK Honvedkorhaz SzemEszeti Osztaly

    Budapest, 1062

  • Semmelweis Egyetem

    Budapest, 1085

  • Bajcsy-Zsilinszky Korhaz es Rendelointezet

    Budapest, 1106

  • Budapest Retina Associates Kft

    Budapest, 1133

  • Jahn Ferenc Dél-Pesti Kórház és Rendelointézet

    Budapest, 1214

Other trials in Hungary

Italy5 sites

  • Ospedale Clinicizzato SS Annunziata

    Chieti, Abruzzo, 66100

  • Ospedale San Raffaele S.r.l. - PPDS

    Milan, Lombardy, 20132

  • Fondazione PTV Policlinico Tor Vergata

    Rome, Lazio, 00133

  • Fondazione Policlinico Universitario A Gemelli

    Rome, Lazio, 00168

  • Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia

    Udine, 33100

Other trials in Italy

Slovakia5 sites

  • Fakultna nemocnica s poliklinikou F. D. Roosevelta

    Banská Bystrica, 974 01

  • Univerzitna nemocnica Bratislava

    Bratislava, 826 06

  • Uvea Klinika, S.R.O.

    Martin, 036 01

  • Nemocnica s poliklinikou Trebisov a.s.

    Trebišov, 075 01

  • Fakultna nemocnica Trencin

    Trencín, 911 01

Other trials in Slovakia

Germany4 sites

  • St. Elisabeth Krankenhaus

    Cologne, North Rhine-Westphalia, 50935

  • Miriam Kannenbaeumer or Andrea Koschinski

    Münster, North Rhine-Westphalia, 48145

  • Dietrich Bonhoeffer Klinikum Neubrandenburg

    Neubrandenburg, Mecklenburg-Vorpommern, 17036

  • Universitätsklinikum Regensburg

    Regensburg, Bavaria, 93053

Other trials in Germany

Latvia4 sites

  • Signes Ozolinas Doctor Praxis In Ophthalmology

    Jelgava, LV-3001

  • Pauls Stradins Clinical University Hospital

    Riga, LV-1002

  • Riga Eastern Clinical University Hospital Clinic Bikernieki

    Riga, LV-1006

  • Latvian American Eye Center

    Riga, LV-1009

Other trials in Latvia

Czechia3 sites

  • OFTEX s.r.o.

    Pardubice, 53002

  • Vseobecna Fakultni

    Prague, 128 08

  • Lekarna BENU

    Prague, 150 00

Other trials in Czechia

Puerto Rico1 site

  • Emanuelli Research & Development Center LLC

    Arecibo, 00612

Other trials in Puerto Rico

About this study

Official title: A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Due to Treatment-naïve Macular Edema Secondary to Retinal Vein Occlusion (RVO)

This Phase 3 study will evaluate the efficacy, durability, and safety of KSI-301 compared to aflibercept, in participants with macular edema due to treatment-naïve branch (BRVO) or central retinal vein occlusion (CRVO).

Read the detailed description

This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with visual impairment due to treatment-naïve macular edema secondary to RVO (either branch or central type).

The primary endpoint will be assessed at Week 24; additional secondary endpoints for efficacy will be assessed at Week 24 and Week 48.

Being tested
KSI-301, Aflibercept, Sham Procedure
Keywords
RVO, Kodiak, KSI-301, Vascular endothelial growth factor, Anti-VEGF, VEGF, Antibody biopolymer conjugate, Retinal Degeneration, Retinal Diseases, Eye Diseases, Vision Disorders, Vision, low, Aflibercept, Eylea
Medical subject headings
Macular Edema, Retinal Vein Occlusion, Retinal Degeneration, Retinal Diseases, Eye Diseases, Vision Disorders, Vision, Low

What participants receive

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

  • KSI-301Drug

    Intravitreal Injection

  • AfliberceptDrug

    Also called Eylea

    Intravitreal Injection

  • Sham ProcedureOther

    The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.

Study groups in NCT04592419
Study groupRoleWhat they receive
KSI-301 (Arm A)ExperimentalIntravitreal injection of KSI-301 (5 mg) at Day 1, Week 4, and once every 8 weeks through Week 20 followed by an individualized dosing regimen of Intravitreal injection of KSI-301 (5 mg) from Week 24 to Week 44. In the Extension Phase, participants randomized to KSI-301 (5 mg) in the Primary Study will continue to receive KSI-301 (5 mg) based on protocol-defined disease activity criteria.
Receives: Drug: KSI-301; Other: Sham Procedure
Aflibercept (Arm B)Active comparatorIntravitreal injection of aflibercept (2 mg) once every 4 through Week 20 followed by an individualized dosing regimen of Intravitreal injection of Aflibercept (2 mg) once every 4 weeks from Week 24 to Week 44. In the Extension Phase, participants randomized to aflibercept in the Primary Study will cross over to treatment with KSI-301 (5 mg). They will receive their first dose of KSI-301 (5 mg) at Week 48 and will receive additional treatment with KSI-301 (5 mg) based on protocol-defined disease activity criteria.
Receives: Drug: Aflibercept; Other: Sham Procedure

What is being measured

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

  1. Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in BRVO Participants.

    BCVA as a continuous variable measured at each study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA approach.

    Measured: Day 1 to Week 24

  2. Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in All RVO Patients.

    BCVA as a continuous variable measured at each study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA approach.

    Measured: Day 1 to Week 24

Secondary outcomes (8)

  1. Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants.

    BCVA as a continuous variable measured at each study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA approach.

    Measured: Day 1 - Week 48

  2. Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants.

    Number of participants in each treatment arm who meet specified criteria at each visit from Week 1 through Week 48. Percentages are 100*n/N.

    Measured: Day 1 - Week 48

  3. Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants

    Number of participants in each treatment arm who meet specified criteria at each visit from Week 1 through Week 48. Percentages are 100*n/N.

    Measured: Day 1 - Week 48

  4. Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants.

    Percentage of participants with BCVA Snellen Equivalent of 20/40 or Better from Baseline to Week 48. Snellen Equivalent of 20/40 is 69 ETDRS letters. Number of participants in each treatment arm who meet specified criteria at each visit from Baseline through Week 48. Percentages are 100*n/N.

    Measured: Day 1 - Week 48.

  5. Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants.

    Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse from Baseline to Week 48. Snellen Equivalent of 20/200 is 38 ETDRS letters. Number of participants in each treatment arm who meet specified criteria at each visit from Baseline through Week 48. Percentages are 100*n/N.

    Measured: Baseline - Week 48

  6. Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants.

    Macular Edema (ME) is assessed by optical coherence tomography (OCT) central subfield thickness (CST). A thickness of less than 325 microns is considered absence of ME. Proportion of participants with Absence of Macular Edema from Baseline to Week 48. Number of participants in each treatment arm who meet specified criteria at each visit from Week 1 through Week 48. Percentages are 100*n/N.

    Measured: Baseline - Week 48

  7. Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants.

    Mean change in OCT central subfield retinal thickness (CST) from baseline by visit over time (up to Week 48) for all RVO participants.

    Measured: Day 1 - Week 48

  8. Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants.

    Mean change in OCT center point retinal thickness (CPT) from baseline by visit over time (up to Week 48) for all RVO participants.

    Measured: Day 1 - Week 48

Timeline

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

  1. First posted19 Oct 2020
  2. Study start25 Sep 2020
  3. Primary completion10 Jun 2022
  4. Study completion19 Jan 2023

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
Model description
Participants will be randomized 1:1 into one of two treatment arms: KSI-301 or aflibercept. Participants in the Extension Phase will be treated with KSI-301.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
568 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04592419
Sponsor's protocol ID
KS301P103
Other IDs
2020-001061-37
Acronym
BEACON
Status last verified
Jun 2024
First submitted
12 Oct 2020
Last updated
26 Jun 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Temkar S, Rajasekar G, Shah AD, Shaikh N, Deb AK, Basa K. Retinal vein occlusion-related macular edema: An updated review of current evidence and future directions. Indian J Ophthalmol. 2026 May 1;74(5):715-723. doi: 10.4103/IJO.IJO_3361_25. Epub 2026 Apr 29.

    PubMed 42054088

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing KSI-301 and Aflibercept in people with Macular Edema and Retinal Vein Occlusion, run by Kodiak Sciences Inc at 141 sites in 12 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 6 inclusion and 12 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 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in United States, Spain, Israel, France, Poland and 7 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 6 Jun 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?

Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in BRVO Participants. (time frame: Day 1 to Week 24). The study lists 2 primary outcomes in all. 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 NCT04592419, 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 26 Jun 2024.

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