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

Primary Purpose

Diabetes Mellitus, Diabetic Retinopathy, Diabetic Macular Edema

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
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
aflibercept 2mg + THR-149 0.13mg
Aflibercept 2mg
Sponsored by
Oxurion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Retinal Research Institute, LLCRecruiting
  • Retina AssociatesRecruiting
  • Retina-Vitreous Associates Medical GroupRecruiting
  • Salehi Retina Institute Inc.Recruiting
  • Northern California Retina Vitreous Associates Medical Group, Inc.Recruiting
  • California Retina ConsultantsRecruiting
  • Retina Consultants San DiegoRecruiting
  • Retinal Consultants Medical GroupRecruiting
  • Retina Consultants of Southern Colorado, P.C.Recruiting
  • Blue Ocean Clinical ResearchRecruiting
  • Fort Lauderdale Eye InstituteRecruiting
  • MedEye AssociatesRecruiting
  • Center for Retina and Macular DiseaseRecruiting
  • Southeast Retina CenterRecruiting
  • University Retina and Macula Associates, PCRecruiting
  • Cumberland Valley Retina ConsultantsRecruiting
  • Joslin Diabetes CenterRecruiting
  • Henry Ford HospitalRecruiting
  • Sierra Eye AssociatesRecruiting
  • Retina-Vitreous Surgeons of Central New York, PCRecruiting
  • Cincinnati Eye InstituteRecruiting
  • University Hospitals Cleveland Medical CenterRecruiting
  • Retina Associates of Cleveland, IncRecruiting
  • Sterling Vision, P.C. dba Oregon RetinaRecruiting
  • Tenneesse RetinaRecruiting
  • Retina Research Institute of TexasRecruiting
  • Austin Research Center for RetinaRecruiting
  • Austin Retina AssociatesRecruiting
  • Retina Research Center, PLLCRecruiting
  • Texas Retina AssociatesRecruiting
  • Houston Eye AssociatesRecruiting
  • Retina Consultants of Houston, PARecruiting
  • Valley Retina Institute, PARecruiting
  • Medical Center Ophthalmology AssociatesRecruiting
  • Retina Associates of South Texas, P.A.Recruiting
  • Retina Consultants of TexasRecruiting
  • Piedmont Eye CenterRecruiting
  • Wagner Macula & Retina CenterRecruiting
  • WVU Eye InstituteRecruiting
  • Axon Clinical
  • Všeobecná fakultní nemocnice v PrazeRecruiting
  • Centre Hospitalier Intercommunal de CréteilRecruiting
  • CHU de DijonRecruiting
  • Hôpital de la Croix RousseRecruiting
  • Centre Paradis MonticelliRecruiting
  • Hôpital LariboisièreRecruiting
  • Fondation RothschildRecruiting
  • Universitätsklinikum Carl Gustav Carus DresdenRecruiting
  • Internationale Innovative OphthalmochirurgieRecruiting
  • Universitätsklinikum FrankfurtRecruiting
  • Universitätsmedizin GöttingenRecruiting
  • Universitätsklinikum Hamburg-EppendorfRecruiting
  • Universitätsklinikum RegensburgRecruiting
  • IRCCS Ospedale San RaffaeleRecruiting
  • Fondazione PTV Policlinico Tor Vergata
  • IRCCS Fondazione G.B. BiettiRecruiting
  • Azienda Sanitaria Universitaria Friuli CentraleRecruiting
  • Univerzitná nemocnica Bratislava, Nemocnica Ružinov
  • Fakultná nemocnica Trenčín
  • Fakultná nemocnica s poliklinikou Žilina
  • Hospital de la EsperanzaRecruiting
  • Hospital Universitari de BellvitgeRecruiting
  • Hospital General de CatalunyaRecruiting
  • Hospital Dos de MaigRecruiting
  • Instituto Clínico Quirúrgico de OftalmologíaRecruiting
  • Hospital La Arruzafa - Instituto de OftalmologiaRecruiting
  • Hospital Universitario Puerta de Hierro MajadahondaRecruiting
  • Instituto Oftalmológico Gómez-UllaRecruiting
  • Hospital Universitario Virgen MacarenaRecruiting
  • FISABIO-Oftalmología MédicaRecruiting
  • Hospital Universitario Rio HortegaRecruiting
  • Hospital Clínico Universitario Lozano BlesaRecruiting
  • University Hospitals Bristol NHS Foundation TrustRecruiting
  • Kent and Canterbury HospitalRecruiting
  • Frimley Health NHS Foundation TrustRecruiting
  • Moorfields Eye Hospital NHS Foundation TrustRecruiting
  • London North West University Healthcare NHS TrustRecruiting
  • King's College Hospital NHS Foundation TrustRecruiting
  • South Tyneside and Sunderland NHS Foundation TrustRecruiting
  • Mid and South Essex NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

THR-149 dose level 1

THR-149 dose level 2

THR-149 dose level 3

THR-149 + sham

THR-149 + aflibercept flip-over

Aflibercept + THR-149 flip-over

Aflibercept + sham

Arm Description

Outcomes

Primary Outcome Measures

Mean change in best-corrected visual acuity (BCVA) ETDRS letter score from Baseline, in subjects in Part B of the study

Secondary Outcome Measures

Mean change in BCVA ETDRS letter score from Baseline, by study visit
Mean change in central subfield thickness (CST) from Baseline, by study visit
Incidence of systemic and ocular adverse events (AEs) and serious adverse events (SAEs)

Full Information

First Posted
August 21, 2020
Last Updated
January 10, 2023
Sponsor
Oxurion
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1. Study Identification

Unique Protocol Identification Number
NCT04527107
Brief Title
A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema
Acronym
KALAHARI
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2020 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oxurion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Diabetic Retinopathy, Diabetic Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
THR-149 dose level 1
Arm Type
Experimental
Arm Title
THR-149 dose level 2
Arm Type
Experimental
Arm Title
THR-149 dose level 3
Arm Type
Experimental
Arm Title
THR-149 + sham
Arm Type
Experimental
Arm Title
THR-149 + aflibercept flip-over
Arm Type
Experimental
Arm Title
Aflibercept + THR-149 flip-over
Arm Type
Active Comparator
Arm Title
Aflibercept + sham
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
THR-149 dose level 1
Intervention Description
3 intravitreal injections of THR-149 dose level 1, 1 month apart
Intervention Type
Drug
Intervention Name(s)
THR-149 dose level 2
Intervention Description
3 intravitreal injections of THR-149 dose level 2, 1 month apart
Intervention Type
Drug
Intervention Name(s)
THR-149 dose level 3
Intervention Description
3 intravitreal injections of THR-149 dose level 3, 1 month apart
Intervention Type
Drug
Intervention Name(s)
THR-149 0.13mg
Intervention Description
3 intravitreal injections of THR-149 0.13mg (selected dose level), 1 month apart, followed after 1 month by a sham (pretend) injection
Intervention Type
Drug
Intervention Name(s)
THR-149 0.13mg + aflibercept 2mg
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
aflibercept 2mg + THR-149 0.13mg
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Aflibercept 2mg
Intervention Description
3 intravitreal injections of aflibercept 2mg, 1 month apart, followed after 1 month by a sham (pretend) injection
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Mean change in BCVA ETDRS letter score from Baseline, by study visit
Time Frame
Up to Month 6
Title
Mean change in central subfield thickness (CST) from Baseline, by study visit
Time Frame
Up to Month 6
Title
Incidence of systemic and ocular adverse events (AEs) and serious adverse events (SAEs)
Time Frame
Up to Month 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: 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 Key Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Global Clinical Development
Phone
+32 (0)16 751 310
Email
info@oxurion.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Department
Organizational Affiliation
Oxurion
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Research Institute, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85053
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Individual Site Status
Recruiting
Facility Name
Salehi Retina Institute Inc.
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Individual Site Status
Recruiting
Facility Name
Northern California Retina Vitreous Associates Medical Group, Inc.
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Individual Site Status
Recruiting
Facility Name
California Retina Consultants
City
Oxnard
State/Province
California
ZIP/Postal Code
93036
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants San Diego
City
Poway
State/Province
California
ZIP/Postal Code
92064
Country
United States
Individual Site Status
Recruiting
Facility Name
Retinal Consultants Medical Group
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Southern Colorado, P.C.
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Individual Site Status
Recruiting
Facility Name
Blue Ocean Clinical Research
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Individual Site Status
Recruiting
Facility Name
Fort Lauderdale Eye Institute
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Individual Site Status
Recruiting
Facility Name
MedEye Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Individual Site Status
Recruiting
Facility Name
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Individual Site Status
Recruiting
Facility Name
Southeast Retina Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Individual Site Status
Recruiting
Facility Name
University Retina and Macula Associates, PC
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Individual Site Status
Recruiting
Facility Name
Cumberland Valley Retina Consultants
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Individual Site Status
Recruiting
Facility Name
Joslin Diabetes Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Individual Site Status
Recruiting
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina-Vitreous Surgeons of Central New York, PC
City
Liverpool
State/Province
New York
ZIP/Postal Code
13088
Country
United States
Individual Site Status
Recruiting
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Associates of Cleveland, Inc
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Individual Site Status
Recruiting
Facility Name
Sterling Vision, P.C. dba Oregon Retina
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Name
Tenneesse Retina
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Research Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Individual Site Status
Recruiting
Facility Name
Austin Research Center for Retina
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Research Center, PLLC
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Individual Site Status
Recruiting
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Houston, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Valley Retina Institute, PA
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Individual Site Status
Recruiting
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Associates of South Texas, P.A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Name
Retina Consultants of Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Individual Site Status
Recruiting
Facility Name
Piedmont Eye Center
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Individual Site Status
Recruiting
Facility Name
Wagner Macula & Retina Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Individual Site Status
Recruiting
Facility Name
WVU Eye Institute
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Individual Site Status
Recruiting
Facility Name
Axon Clinical
City
Prague
ZIP/Postal Code
150 00
Country
Czechia
Individual Site Status
Withdrawn
Facility Name
Všeobecná fakultní nemocnice v Praze
City
Praha 2
ZIP/Postal Code
12800
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Intercommunal de Créteil
City
Créteil
ZIP/Postal Code
94010
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de Dijon
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital de la Croix Rousse
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Paradis Monticelli
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Name
Hôpital Lariboisière
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Individual Site Status
Recruiting
Facility Name
Fondation Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Carl Gustav Carus Dresden
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Internationale Innovative Ophthalmochirurgie
City
Düsseldorf
ZIP/Postal Code
40549
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsmedizin Göttingen
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale San Raffaele
City
Milan
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Fondazione PTV Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Individual Site Status
Withdrawn
Facility Name
IRCCS Fondazione G.B. Bietti
City
Roma
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Sanitaria Universitaria Friuli Centrale
City
Udine
Country
Italy
Individual Site Status
Recruiting
Facility Name
Univerzitná nemocnica Bratislava, Nemocnica Ružinov
City
Bratislava
ZIP/Postal Code
82606
Country
Slovakia
Individual Site Status
Withdrawn
Facility Name
Fakultná nemocnica Trenčín
City
Trenčín
ZIP/Postal Code
911 71
Country
Slovakia
Individual Site Status
Withdrawn
Facility Name
Fakultná nemocnica s poliklinikou Žilina
City
Žilina
ZIP/Postal Code
012 07
Country
Slovakia
Individual Site Status
Terminated
Facility Name
Hospital de la Esperanza
City
Barcelona
ZIP/Postal Code
08024
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari de Bellvitge
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital General de Catalunya
City
Barcelona
ZIP/Postal Code
8195
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Dos de Maig
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Name
Instituto Clínico Quirúrgico de Oftalmología
City
Bilbao
ZIP/Postal Code
480006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital La Arruzafa - Instituto de Oftalmologia
City
Córdoba
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Puerta de Hierro Majadahonda
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Instituto Oftalmológico Gómez-Ulla
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
FISABIO-Oftalmología Médica
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Rio Hortega
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Clínico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
University Hospitals Bristol NHS Foundation Trust
City
Bristol
ZIP/Postal Code
BS1 2LX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Kent and Canterbury Hospital
City
Canterbury
ZIP/Postal Code
CT1 3NG
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Frimley Health NHS Foundation Trust
City
Frimley
ZIP/Postal Code
GU16 7UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Moorfields Eye Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
London North West University Healthcare NHS Trust
City
London
ZIP/Postal Code
NW10 7NS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
King's College Hospital NHS Foundation Trust
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
South Tyneside and Sunderland NHS Foundation Trust
City
Sunderland
ZIP/Postal Code
SR2 9HP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Mid and South Essex NHS Foundation Trust
City
Westcliff-on-Sea
ZIP/Postal Code
SS0 ORY
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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