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

BCN Peptides

Status and phase: Completed; Phase 3; Phase 2

Conditions: Diabetic Retinopathy

Treatments: Drug: COLIRIOBCN070660; Drug: Brimonidine; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01726075

4C-2011-02

2012-001200-38 (EudraCT Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 450 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

450 participants in 3 patient groups, including a placebo group

COLIRIOBCN070660

Experimental group

Description:

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

Treatment:

Drug: COLIRIOBCN070660

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Brimonidine

Experimental group

Description:

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

Treatment:

Drug: Brimonidine