A multicentric, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of COLIRIOBCN070660 administered topically in patients with moderately severe to severe non-proliferative diabetic retinopathy

Prior treatment

• History of YAG capsulotomy in the study eye performed within the last 2 months prior to Screening.
• History of DME or DR treatment with laser photocoagulation in the study eye or intraocular injections of steroids or anti-VEGF medication in any of the two eyes within the prior 12 months to Screening.
• Active glaucoma treatment with prostaglandin analogues or carbonic anhydrase inhibitors. Alfa agonists and beta blockers are allowed.
• Somatostatin treatment, for any indication, in the previous 3 months from Screening.
• Participation in an investigational study within 30 days prior to Screening visit that involved treatment with any drug (excluding vitamins and minerals) or device.
• History of major ocular surgery in the study eye (cataract/glaucoma/retinal detachment surgery) within prior 6 months of Screening.

Other illness

• Patients that change diabetes mellitus treatment (including initiation of insulin treatment) in the last 4 months, or plan to do so along the study.
• Renal failure, dialysis or history of renal implant.
• Condition or 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.
• Hypersensitivity to the active substance to be tested or to any of the excipients.
• Known allergy to fluorescein dye.
• Current ASNV (Anterior Segment Neovascularization), vitreous haemorrhage, or tractional retinal detachment in the study eye.
• Any ocular condition (other than DR) in the study eye that, in the opinion of the investigator, would prevent a visual acuity improvement (e.g., clinical signs of glaucoma, clinically relevant cataract).
• Evidence of active inflammation or infection in either eye, including very frequent and chronic inflammations such as blepharitis and conjunctivitis.
• History of aphakia in the study eye.

Lab values

• HbA1C > 10.5 % at Screening.

Other

• Presence of CI-DME or other pathologies involving edema in the study eye, confirmed by evaluation of OCT images measured by the Central Reading Center (CRC) according to the following thresholds for Zeiss Cirrus: - ≥ 290 μm in women - ≥ 305 μm in men
• Subject with a refractive error ≥ ± 5 diopter in the Study eye.
• Inadequate ocular media, pupil dilatation or lack of cooperation to obtain CFP, FA and OCT images with sufficient quality.
• Uncontrolled blood pressure (defined as systolic > 180 mm Hg and/or diastolic > 110 mmHg while patient is sitting).
• Presence of retinal neovascularization in the study eye on clinical exam, by 7-field or ultra-widefield CFP.
• Pregnant or nursing or intending to become pregnant along the study.
• Intraocular pressure (IOP) ≥ 22 mm Hg in the study eye.
• Presence of clinical signs of glaucoma in the study eye.

• Men or women with ≥ 18 years old at the time of signing the informed consent.
• Diagnosis of diabetes mellitus (type I or type II).
• Moderately severe or severe NPDR (ETDRS levels 47 or 53) in the Study Eye as determined by the Central Reading Centre.
• BCVA ETDRS letter score in the Study eye of ≥60 letters (approximate Snellen equivalent of 20/63 or better).
• Willing and able to comply with clinic visits and study-related procedures.
• Provide a signed informed consent.