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Diabetic RetinopathyPhase 2/3EUROCONDORNCT01726075

Trial to Assess the Efficacy of Neuroprotective Drugs Administered Topically to Prevent or Arrest Diabetic Retinopathy

A Phase 2/3 study testing COLIRIOBCN070660 and Brimonidine in people with Diabetic Retinopathy, run by BCN Peptides at 11 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes Read more about this study

Who is it for?
Ages 45 to 75 years
Conditions the study is for
Diabetic Retinopathy
What is being tested?
COLIRIOBCN070660 and Brimonidine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
450 participants
Where
11 sitesin 7 countries
Study dates
Feb 2013to Nov 2015
Phase
Phase 2/3
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 45 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with type 2 diabetes mellitus
  • Diabetes duration ≥ 5 years
  • Aged between 45-75 years-old
  • ETDRS level < 20 (microaneurysms absent) (50% of enrolled patients) Or ETDRS levels 20 or 35 with presence of at least one microaneurysm in Field 2 between the superior and inferior arcades (50% of enrolled patients) in the Study Eye as determined by the Reading Centre.
  • Informed Consent

Who cannot join

  • Previous laser photocoagulation
  • Other diseases which may induce retinal degeneration (e.g. glaucoma)
  • Subject with a refractive error ≥ ± 5 diopter
  • Inadequate ocular media and/ or pupil dilatation that do not permit good quality fundus photography.
  • Renal failure (creatinine > 1.4 mg/dl)
  • HbA1C > 10 % in the previous 6 months and at Screening
Show all 11Show fewer
  • Subjects taking somatostatin or brimonidine, for any indication, in the previous 3 months
  • Subject has a condition or is in a situation which may put the subject at significant risk, may confound the study results or may interfere significantly with the patient's participation in the study.
  • Pregnancy or nursing
  • Hypersensitivity to the active substances to be tested or to any of the excipients
  • Subject receiving systemic monoamine oxidase (MAO) inhibitor therapy or antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin)

Trial locations and contacts

11 sites in 7 countries.

11 sites in 7 countries

United Kingdom4 sites

  • Aston University (UAston)Heart of England NHS Foundation Trust

    Birmingham

  • Gloucestershire Hospitals NHS Foundation Trust (CHGH)

    Cheltenham, Gloucestershire

  • The University of Liverpool (UOL)

    Liverpool

  • Moorfields Eye Hospital NHS Foundation Trust (MEH)

    London, London, EC1V2PD

Other trials in United Kingdom

Italy2 sites

  • Universita Vita-Salute San Raffaele (USR)

    Milan, 20132

  • Universita degli Study di Padova(UPadova)

    Padova, 35128

Other trials in Italy

Denmark1 site

  • Syddansk Universitet (SDU)

    Odense

Other trials in Denmark

France1 site

  • AP - Hopitaux de Paris (AP-HP)

    Paris, Paris, 75010

Other trials in France

Germany1 site

  • Universitaet Ulm (UUlm)

    Ulm, 89081

Other trials in Germany

Portugal1 site

  • Aibili - Cec

    Coimbra, Coimbra District, 3000-548

Other trials in Portugal

Spain1 site

  • Institut Catala de la Salut - Hospital Universitari Vall d'Hebron (ICS-HUVH)

    Barcelona, Barcelona, 08035

Other trials in Spain

About this study

Official title: Neurodegeneration as Early Event in Pathogenesis of Diabetic Retinopathy:Multicentric, Prospective, Ph. II-III,Random.Controlled Trial to Assess Efficacy of Neuroprotective Drugs Administered Topically to Prevent/Arrest Diabetic Retinopathy

To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes

Read the detailed description

To assess whether neuroprotective drugs administered topically (somatostatin and brimonidine) are able to prevent or arrest the development and progression of neurodegenerative changes related to diabetic retinopathy.

Being tested
COLIRIOBCN070660, Placebo, Brimonidine
Keywords
diabetic retinopathy
Medical subject headings
Diabetic Retinopathy

What participants receive

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

  • COLIRIOBCN070660Drug

    Also called Somatostatin eye drops

    One drop per eye twice a day during 24 months

  • PlaceboDrug

    Also called placebo eye drops

    One drop per eye twice a day during 24 months

  • BrimonidineDrug

    Also called Brimonidine eye drops

    One drop per eye twice a day during 24 months

Study groups in NCT01726075
Study groupRoleWhat they receive
COLIRIOBCN070660ExperimentalCOLIRIOBCN070660 Somatostatin 1mg/mL Eye drops, solution. One drop/eye administered twice a day.
Receives: Drug: COLIRIOBCN070660
PlaceboPlacebo comparatorPlacebo Eye drops, solution. One drop/eye administered twice a day.
Receives: Drug: Placebo
BrimonidineExperimentalBrimonidine tartrate 2mg/mL One drop/eye administered twice a day.
Receives: Drug: Brimonidine

What is being measured

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

  1. Changes in the Implicit Time assessed by mfERG (IT-mfERG) at month 6, 12, 18 and 24

    Measured: month 24

Secondary outcomes (27)

  1. Retinal Nerve Fiber Layer (RNFL) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) at month 0

    Measured: month 0

  2. Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 6

    Measured: month 6

  3. Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 12

    Measured: month 12

  4. Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 18

    Measured: month 18

  5. Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 24

    Measured: month 24

  6. Ganglion Cell Layer (GCL) assessed by SD-OCT at month 0

    Measured: month 0

  7. Ganglion Cell Layer (GCL) assessed by SD-OCT at month 6

    Measured: month 6

  8. Ganglion Cell Layer (GCL) assessed by SD-OCT at month 12

    Measured: month 12

  9. Ganglion Cell Layer (GCL) assessed by SD-OCT at month 18

    Measured: month 18

  10. Ganglion Cell Layer (GCL) assessed by SD-OCT at month 24

    Measured: month 24

  11. Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at baseline

    Measured: baseline

  12. Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 6

    Measured: month 6

  13. Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 12

    Measured: month 12

  14. Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 18

    Measured: month 18

  15. Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 24

    Measured: month 24

  16. Retinal thickness assessed by SD-OCT at month 0

    Measured: month 0

  17. Retinal thickness assessed by SD-OCT at month 6

    Measured: month 6

  18. Retinal thickness assessed by SD-OCT at month 12

    Measured: month 12

  19. Retinal thickness assessed by SD-OCT at month 18

    Measured: month 18

  20. Retinal thickness assessed by SD-OCT at month 24

    Measured: month 24

  21. Central retinal thickness assessed by SD-OCT at month 0

    Measured: month 0

  22. Central retinal thickness assessed by SD-OCT at month 6

    Measured: month 6

  23. Central retinal thickness assessed by SD-OCT at month 12

    Measured: month 12

  24. Central retinal thickness assessed by SD-OCT at month 18

    Measured: month 18

  25. Central retinal thickness assessed by SD-OCT at month 24

    Measured: month 24

  26. Diabetic Retinopathy (DR) severity assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) scale CFP - 30º/35º-7 fields at baseline

    Measured: baseline

  27. DR severity assessed by ETDRS scale CFP - 30º/35º-7 fields at month 24

    Measured: month 24

Timeline

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

  1. First posted14 Nov 2012 (estimated)
  2. Study startFeb 2013
  3. Primary completionNov 2015
  4. Study completionNov 2015

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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
450 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01726075
Sponsor's protocol ID
4C-2011-02
Other IDs
2012-001200-38
Acronym
EUROCONDOR
Status last verified
Jan 2016
First submitted
7 Nov 2012
Last updated
12 Jan 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Cunha-Vaz J, Ribeiro L, Costa M, Simo R. Diabetic Retinopathy Phenotypes of Progression to Macular Edema: Pooled Analysis From Independent Longitudinal Studies of up to 2 Years' Duration. Invest Ophthalmol Vis Sci. 2017 May 1;58(6):BIO206-BIO210. doi: 10.1167/iovs.17-21780.

    PubMed 28785768

  • Santos AR, Ribeiro L, Bandello F, Lattanzio R, Egan C, Frydkjaer-Olsen U, Garcia-Arumi J, Gibson J, Grauslund J, Harding SP, Lang GE, Massin P, Midena E, Scanlon P, Aldington SJ, Simao S, Schwartz C, Ponsati B, Porta M, Costa MA, Hernandez C, Cunha-Vaz J, Simo R; European Consortium for the Early Treatment of Diabetic Retinopathy (EUROCONDOR). Functional and Structural Findings of Neurodegeneration in Early Stages of Diabetic Retinopathy: Cross-sectional Analyses of Baseline Data of the EUROCONDOR Project. Diabetes. 2017 Sep;66(9):2503-2510. doi: 10.2337/db16-1453. Epub 2017 Jun 29.

    PubMed 28663190

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing COLIRIOBCN070660 and Brimonidine in people with Diabetic Retinopathy, run by BCN Peptides at 11 sites in 7 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 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 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United Kingdom, Italy, Denmark, France, Germany and 2 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

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?

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?

Changes in the Implicit Time assessed by mfERG (IT-mfERG) at month 6, 12, 18 and 24 (time frame: month 24). 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 NCT01726075, which also lists 2 linked publications.

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 12 Jan 2016.

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