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Diabetes MellitusPhase 2KALAHARINCT04527107

A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema

A Phase 2 study testing THR-149 dose level 1, THR-149 dose level 2 and THR-149 dose level 3 in people with Diabetes Mellitus and Diabetic Retinopathy, run by Oxurion at 78 sites in 8 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

Part A of the study is conducted to select the THR-149 dose level. Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
THR-149 dose level 1, THR-149 dose level 2 and THR-149 dose level 3
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
135 participants
Where
78 sitesin 8 countries
Study dates
31 Jul 2020to 22 Nov 2023
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written informed consent obtained from the subject prior to screening procedures
  • Male or female aged 18 years or older at the time of signing the informed consent
  • Type 1 or type 2 diabetes
  • BCVA ETDRS letter score ≤ 73 and ≥ 39 in the study eye (for subjects in Part A); BCVA ETDRS letter score ≤ 73 and ≥ 24 in the study eye (for subjects in Part B)
  • Central involved DME (CI-DME) with CST of ≥ 320µm in men or ≥ 305µm in women, on spectral domain optical coherence tomography (SD-OCT), in the study eye
  • Received ≥ 5 anti-vascular endothelial growth factor (anti-VEGF) injections for the treatment of CI-DME
  • BCVA ETDRS letter score ≥ 34 in the fellow eye

Who cannot join

  • Macular edema due to causes other than DME in the study eye
  • Concurrent disease in the study eye, other than central-involved DME, that could require medical or surgical intervention during the study period or could confound interpretation of the results
  • Any condition that could confound the ability to detect the efficacy of the investigational medicinal product
  • Previous confounding medications / interventions, or their planned administration
  • Presence of neovascularisation at the disc in the study eye
  • Presence of iris neovascularisation in the study eye
Show all 11Show fewer
  • Uncontrolled glaucoma in the study eye
  • Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
  • Untreated Diabetes Mellitus
  • Glycated haemoglobin A (HbA1c) > 12%
  • Uncontrolled hypertension

Trial locations and contacts

78 sites in 8 countries.

78 sites in 8 countries

United States41 sites

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Research Center for Retina

    Austin, Texas, 78705

  • Austin Retina Associates

    Austin, Texas, 78705

  • Retina Research Center, PLLC

    Austin, Texas, 78705

  • Retina-Vitreous Associates Medical Group

    Beverly Hills, California, 90211

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242

  • Blue Ocean Clinical Research

    Clearwater, Florida, 33761

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Retina Associates of Cleveland, Inc

    Cleveland, Ohio, 44122

  • Retina Consultants of Southern Colorado, P.C.

    Colorado Springs, Colorado, 80909

  • Texas Retina Associates

    Dallas, Texas, 75231

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Sterling Vision, P.C. dba Oregon Retina

    Eugene, Oregon, 97401

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Houston Eye Associates

    Houston, Texas, 77025

  • Retina Consultants of Houston, PA

    Houston, Texas, 77030

  • Salehi Retina Institute Inc.

    Huntington Beach, California, 92647

  • Retina-Vitreous Surgeons of Central New York, PC

    Liverpool, New York, 13088

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

  • Marietta Eye Clinic

    Marietta, Georgia, 30060

  • Valley Retina Institute, PA

    McAllen, Texas, 78503

  • WVU Eye Institute

    Morgantown, West Virginia, 26505

  • Northern California Retina Vitreous Associates Medical Group, Inc.

    Mountain View, California, 94040

  • Tenneesse Retina

    Nashville, Tennessee, 37203

  • Wagner Macula & Retina Center

    Norfolk, Virginia, 23502

  • University Retina and Macula Associates, PC

    Oak Forest, Illinois, 60452

  • California Retina Consultants

    Oxnard, California, 93036

  • Retinal Research Institute, LLC

    Phoenix, Arizona, 85053

  • Fort Lauderdale Eye Institute

    Plantation, Florida, 33324

  • Retina Consultants San Diego

    Poway, California, 92064

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • Retinal Consultants Medical Group

    Sacramento, California, 95825

  • Retina Associates of Utah

    Salt Lake City, Utah, 27560

  • Medical Center Ophthalmology Associates

    San Antonio, Texas, 78240

  • Retina Associates of South Texas, P.A.

    San Antonio, Texas, 78240

  • Retina Consultants of Texas

    San Antonio, Texas, 78240

  • MedEye Associates

    South Miami, Florida, 33143

  • Retina Associates

    Tucson, Arizona, 85704

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880

Other trials in United States

Spain12 sites

  • Hospital de la Esperanza

    Barcelona, 08024

  • Hospital Universitari de Bellvitge

    Barcelona, 08907

  • Hospital General de Catalunya

    Barcelona, 8195

  • Hospital Dos de Maig

    Barcelona

  • Instituto Clínico Quirúrgico de Oftalmología

    Bilbao, 480006

  • METAVISIÓN ARRUZAFA, S.L.Clínica de Oftalmología de Córdoba S.L. (Hospital La Arruzafa)

    Córdoba, 14012

  • Hospital Universitario Puerta de Hierro Majadahonda

    Madrid, 28222

  • Instituto Oftalmológico Gómez-Ulla

    Santiago de Compostela, 15706

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Fundación de Oftalmología Médica de la Comunitat Valenciana

    Valencia, 46015

  • Hospital Universitario Rio Hortega

    Valladolid, 47012

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

United Kingdom8 sites

  • University Hospitals Bristol NHS Foundation Trust

    Bristol, BS1 2LX

  • Kent and Canterbury Hospital

    Canterbury, CT1 3NG

  • Frimley Health NHS Foundation Trust

    Frimley, GU16 7UJ

  • Moorfields Eye Hospital NHS Foundation Trust

    London, EC1V 2PD

  • London North West University Healthcare NHS Trust

    London, NW10 7NS

  • King's College Hospital NHS Foundation Trust

    London, SE5 9RS

  • South Tyneside and Sunderland NHS Foundation Trust

    Sunderland, SR2 9HP

  • Mid and South Essex NHS Foundation Trust

    Westcliff-on-Sea, SS0 ORY

Other trials in United Kingdom

France6 sites

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94010

  • CHU de Dijon

    Dijon

  • Hôpital de la Croix Rousse

    Lyon

  • Centre Paradis Monticelli

    Marseille

  • Fondation Rothschild

    Paris, 75019

  • Hôpital Lariboisière

    Paris, 75475

Other trials in France

Germany6 sites

  • Universitätsklinikum Carl Gustav Carus Dresden

    Dresden, 01307

  • Internationale Innovative Ophthalmochirurgie

    Düsseldorf, 40549

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, 60590

  • Universitätsmedizin Göttingen

    Göttingen, 37075

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Universitätsklinikum Regensburg

    Regensburg, 93053

Other trials in Germany

Italy3 sites

  • IRCCS Ospedale San Raffaele

    Milan, 20132

  • IRCCS Fondazione G.B. Bietti

    Roma, 00184

  • Azienda Sanitaria Universitaria Friuli Centrale

    Udine

Other trials in Italy

Czechia1 site

  • Všeobecná fakultní nemocnice v Praze

    Prague, 12800

Other trials in Czechia

Slovakia1 site

  • Fakultná nemocnica s poliklinikou Žilina

    Žilina, 012 07

Other trials in Slovakia

About this study

Official title: A Phase 2, Randomised, Multicentre Study to Assess the Dose Level of Multiple THR-149 Injections and to Evaluate the Efficacy and Safety of THR-149 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME)

Part A of the study is conducted to select the THR-149 dose level.

Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.

Being tested
THR-149 dose level 1, THR-149 dose level 2, THR-149 dose level 3, THR-149 0.13mg, THR-149 0.13mg + aflibercept 2mg
Medical subject headings
Diabetes Mellitus, Diabetic Retinopathy

What participants receive

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

  • THR-149 dose level 1Drug

    3 intravitreal injections of THR-149 dose level 1, 1 month apart

  • THR-149 dose level 2Drug

    3 intravitreal injections of THR-149 dose level 2, 1 month apart

  • THR-149 dose level 3Drug

    3 intravitreal injections of THR-149 dose level 3, 1 month apart

  • THR-149 0.13mgDrug

    3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by a sham (pretend) injection

  • THR-149 0.13mg + aflibercept 2mgDrug

    3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by an intravitreal injection of aflibercept 2mg

  • aflibercept 2mg + THR-149 0.13mgDrug

    3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by an intravitreal injection of THR-149 0.13mg (selected dose level)

  • Aflibercept 2mgDrug

    3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by a sham (pretend) injection

Study groups in NCT04527107
Study groupRoleWhat they receive
THR-149 dose level 1ExperimentalNot described
Receives: Drug: THR-149 dose level 1
THR-149 dose level 2ExperimentalNot described
Receives: Drug: THR-149 dose level 2
THR-149 dose level 3ExperimentalNot described
Receives: Drug: THR-149 dose level 3
THR-149 + shamExperimentalNot described
Receives: Drug: THR-149 0.13mg
THR-149 + aflibercept flip-overExperimentalNot described
Receives: Drug: THR-149 0.13mg + aflibercept 2mg
Aflibercept + THR-149 flip-overActive comparatorNot described
Receives: Drug: aflibercept 2mg + THR-149 0.13mg
Aflibercept + shamActive comparatorNot described
Receives: Drug: Aflibercept 2mg

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) ETDRS letter score from Baseline, in subjects in Part B of the study

    Measured: At Month 3

Secondary outcomes (3)

  1. Mean change in BCVA ETDRS letter score from Baseline, by study visit

    Measured: Up to Month 6

  2. Mean change in central subfield thickness (CST) from Baseline, by study visit

    Measured: Up to Month 6

  3. Incidence of systemic and ocular adverse events (AEs) and serious adverse events (SAEs)

    Measured: Up to Month 6

Timeline

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

  1. First posted26 Aug 2020
  2. Study start31 Jul 2020
  3. Primary completion28 Sep 2023
  4. Study completion22 Nov 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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04527107
Sponsor's protocol ID
THR-149-002
Other IDs
2019-001506-17, 2019
Acronym
KALAHARI
Status last verified
Nov 2023
First submitted
21 Aug 2020
Last updated
27 Nov 2023
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing THR-149 dose level 1, THR-149 dose level 2 and THR-149 dose level 3 in people with Diabetes Mellitus and Diabetic Retinopathy, run by Oxurion at 78 sites in 8 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 7 inclusion and 11 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 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United States, Spain, United Kingdom, France, Germany and 3 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 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 in best-corrected visual acuity (BCVA) ETDRS letter score from Baseline, in subjects in Part B of the study (time frame: At Month 3). 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 NCT04527107.

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 27 Nov 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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