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

Diabetic Retinopathy Clinical Trial

— EUROCONDOR  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01726075
• Other study ID #: 4C-2011-02
• Secondary ID: 2012-001200-38
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 7, 2012
• Last updated: January 11, 2016
• Start date: February 2013
• Est. completion date: November 2015

Study information

• Verified date: January 2016
• Source: BCN Peptides
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos SanitariosSpain: Comité Ético de Investigación ClínicaFrance: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of PersonnesDenmark: Danish Health and Medicines AuthorityDenmark: Ethics CommitteeUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited Kingdom: Research Ethics CommitteePortugal: Ethics Committee for Clinical ResearchGermany: Ministry of HealthItaly: Ethics Committee
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Patients with type 2 diabetes mellitus

2. Diabetes duration = 5 years

3. Aged between 45-75 years-old

4. 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.

5. Informed Consent

Exclusion Criteria:

1. Previous laser photocoagulation

2. Other diseases which may induce retinal degeneration (e.g. glaucoma)

3. Subject with a refractive error = ± 5 diopter

4. Inadequate ocular media and/ or pupil dilatation that do not permit good quality fundus photography.

5. Renal failure (creatinine > 1.4 mg/dl)

6. HbA1C > 10 % in the previous 6 months and at Screening

7. Subjects taking somatostatin or brimonidine, for any indication, in the previous 3 months

8. 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.

9. Pregnancy or nursing

10. Hypersensitivity to the active substances to be tested or to any of the excipients

11. Subject receiving systemic monoamine oxidase (MAO) inhibitor therapy or antidepressants which affect noradrenergic transmission (e.g. tricyclic antidepressants and mianserin)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• COLIRIOBCN070660
One drop per eye twice a day during 24 months
• Placebo
One drop per eye twice a day during 24 months
• Brimonidine
One drop per eye twice a day during 24 months

Locations

Country	Name	City	State
Denmark	Syddansk Universitet (SDU)	Odense
France	AP - Hopitaux de Paris (AP-HP)	Paris
Germany	Universitaet Ulm (UUlm)	Ulm
Italy	Universita Vita-Salute San Raffaele (USR)	Milano
Italy	Universita degli Study di Padova(UPadova)	Padova
Portugal	Aibili - Cec	Coimbra
Spain	Institut Catala de la Salut - Hospital Universitari Vall d'Hebron (ICS-HUVH)	Barcelona
United Kingdom	Aston University (UAston)Heart of England NHS Foundation Trust	Birmingham
United Kingdom	Gloucestershire Hospitals NHS Foundation Trust (CHGH)	Cheltenham	Gloucestershire
United Kingdom	The University of Liverpool (UOL)	Liverpool
United Kingdom	Moorfields Eye Hospital NHS Foundation Trust (MEH)	London

Sponsors (1)

Lead Sponsor	Collaborator
BCN Peptides

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Italy,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Best Corrected Visual Acuity (BCVA) assessed by ETDRS scale at month 0		month 0	Yes
Other	BCVA assessed by ETDRS scale at month 6		month 6	Yes
Other	BCVA assessed by ETDRS scale at month 12		month 12	Yes
Other	BCVA assessed by ETDRS scale at month 18		month 18	Yes
Other	BCVA assessed by ETDRS scale at month 24		month 24	Yes
Other	Visual Fields defects assessed by Visual Fields Test at month 0		month 0	Yes
Other	Visual Fields defects assessed by Visual Fields Test at month 24		month 24	Yes
Other	Visual health assessed by Visual Function Questionnaire (VFQ-25) at month 0		month 0	No
Other	Visual health assessed by Visual Function Questionnaire (VFQ-25) at month 24		month 24	No
Other	Adverse Events assessed by inquiry at month 0		month 0	Yes
Other	Adverse Events assessed by inquiry at month 3		month 3	Yes
Other	Adverse Events assessed by inquiry at month 6		month 6	Yes
Other	Adverse Events assessed by inquiry at month 12		month 12	Yes
Other	Adverse Events assessed by inquiry at month 18		month 18	Yes
Other	Adverse Events assessed by inquiry at month 24		month 24	Yes
Other	ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 0		month 0	Yes
Other	ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 3		month 3	Yes
Other	ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 6		month 6	Yes
Other	ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 12		month 12	Yes
Other	ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 18		month 18	Yes
Other	ophthalmological examination: Refractive Error, Slit Lamp Exam, Ophthalmoscopy (Vitreous, Retina, Macula, Choroid, Optic Nerve), Intra-Ocular Pressure (IOP) Measurement at month 24		month 24	Yes
Primary	Changes in the Implicit Time assessed by mfERG (IT-mfERG) at month 6, 12, 18 and 24		month 24	No
Secondary	Retinal Nerve Fiber Layer (RNFL) assessed by Spectral Domain Optical Coherence Tomography (SD-OCT) at month 0		month 0	Yes
Secondary	Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 6		month 6	Yes
Secondary	Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 12		month 12	Yes
Secondary	Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 18		month 18	Yes
Secondary	Retinal Nerve Fiber Layer (RNFL) assessed by SD-OCT at month 24		month 24	Yes
Secondary	Ganglion Cell Layer (GCL) assessed by SD-OCT at month 0		month 0	Yes
Secondary	Ganglion Cell Layer (GCL) assessed by SD-OCT at month 6		month 6	Yes
Secondary	Ganglion Cell Layer (GCL) assessed by SD-OCT at month 12		month 12	Yes
Secondary	Ganglion Cell Layer (GCL) assessed by SD-OCT at month 18		month 18	Yes
Secondary	Ganglion Cell Layer (GCL) assessed by SD-OCT at month 24		month 24	Yes
Secondary	Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at baseline		baseline	Yes
Secondary	Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 6		month 6	Yes
Secondary	Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 12		month 12	Yes
Secondary	Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 18		month 18	Yes
Secondary	Microaneurysm turnover assessed by Colour Fundus Photography (CFP - 45º/50º Field 2) at month 24		month 24	Yes
Secondary	Retinal thickness assessed by SD-OCT at month 0		month 0	Yes
Secondary	Retinal thickness assessed by SD-OCT at month 6		month 6	Yes
Secondary	Retinal thickness assessed by SD-OCT at month 12		month 12	Yes
Secondary	Retinal thickness assessed by SD-OCT at month 18		month 18	Yes
Secondary	Retinal thickness assessed by SD-OCT at month 24		month 24	Yes
Secondary	Central retinal thickness assessed by SD-OCT at month 0		month 0	Yes
Secondary	Central retinal thickness assessed by SD-OCT at month 6		month 6	Yes
Secondary	Central retinal thickness assessed by SD-OCT at month 12		month 12	Yes
Secondary	Central retinal thickness assessed by SD-OCT at month 18		month 18	Yes
Secondary	Central retinal thickness assessed by SD-OCT at month 24		month 24	Yes
Secondary	Diabetic Retinopathy (DR) severity assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) scale CFP - 30º/35º-7 fields at baseline		baseline	Yes
Secondary	DR severity assessed by ETDRS scale CFP - 30º/35º-7 fields at month 24		month 24	Yes