NCT01726075

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2013

Geographic Reach
7 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 7, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 14, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

2.7 years

First QC Date

November 7, 2012

Last Update Submit

January 11, 2016

Conditions

Diabetic Retinopathy

Keywords

diabetic retinopathy

Outcome Measures

Primary Outcomes (1)

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

    month 24

Secondary Outcomes (27)

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

    month 0

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

    month 6

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

    month 12

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

    month 18

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

    month 24

  • +22 more secondary outcomes

Other Outcomes (21)

  • Best Corrected Visual Acuity (BCVA) assessed by ETDRS scale at month 0

    month 0

  • BCVA assessed by ETDRS scale at month 6

    month 6

  • BCVA assessed by ETDRS scale at month 12

    month 12

  • +18 more other outcomes

Study Arms (3)

COLIRIOBCN070660

EXPERIMENTAL

COLIRIOBCN070660 Somatostatin 1mg/mL Eye drops, solution. One drop/eye administered twice a day.

Drug: COLIRIOBCN070660

Placebo

PLACEBO COMPARATOR

Placebo Eye drops, solution. One drop/eye administered twice a day.

Drug: Placebo

Brimonidine

EXPERIMENTAL

Brimonidine tartrate 2mg/mL One drop/eye administered twice a day.

Drug: Brimonidine

Interventions

COLIRIOBCN070660DRUG

One drop per eye twice a day during 24 months

Also known as: Somatostatin eye drops
COLIRIOBCN070660
PlaceboDRUG

One drop per eye twice a day during 24 months

Also known as: placebo eye drops
Placebo
BrimonidineDRUG

One drop per eye twice a day during 24 months

Also known as: Brimonidine eye drops
Brimonidine

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Syddansk Universitet (SDU)

Odense, Denmark

Location

AP - Hopitaux de Paris (AP-HP)

Paris, Paris, 75010, France

Location

Universitaet Ulm (UUlm)

Ulm, 89081, Germany

Location

Universita Vita-Salute San Raffaele (USR)

Milan, 20132, Italy

Location

Universita degli Study di Padova(UPadova)

Padua, 35128, Italy

Location

Aibili - Cec

Coimbra, Coimbra District, 3000-548, Portugal

Location

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

Barcelona, Barcelona, 08035, Spain

Location

Gloucestershire Hospitals NHS Foundation Trust (CHGH)

Cheltenham, Gloucestershire, United Kingdom

Location

Moorfields Eye Hospital NHS Foundation Trust (MEH)

London, London, EC1V2PD, United Kingdom

Location

Aston University (UAston)Heart of England NHS Foundation Trust

Birmingham, United Kingdom

Location

The University of Liverpool (UOL)

Liverpool, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 28785768DERIVED

  • 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.

    PMID: 28663190DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

QuinoxalinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • José Cunha-Vaz, Prof.

    Association for Innovation and Biomedical Research on Light and Image

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2012

First Posted

November 14, 2012

Study Start

February 1, 2013

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

January 12, 2016

Record last verified: 2016-01

Locations

PT(1)ES(1)GB(4)DK(1)FR(1)IT(2)DE(1)