DIAMOND1
Research type
Research Study
Full title
A Phase 2/3 Double-masked, Randomized, 2 stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects with Diabetic Macular Edema (Stage 2 only)
IRAS ID
1009201
Contact name
Bastian Dehmel
Contact email
Sponsor organisation
Oculis Operations Sàrl
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
Research summary
Diabetic macular (o)edema (DMO/DME) is a common complication of diabetes mellitus which if untreated, leads to vision loss. Medications that prevent inflammation or blood vessel growth play an increasing role in the treatment of DME. To reach the retina, treatments must be injected, or slow-release drug capsules surgically implanted into the eye, which is invasive and traumatic for patients. In this study, an eye-drop formulation called OCS-01 is being investigated for its safety and ability to treat DME effectively. It is important to develop less invasive and more efficacious treatments for DME patients as 1 in 14 people with diabetes will develop DME, leading to a reduced quality of life for these individuals.
OCS-01 is a 1.5% dexamethasone suspension which is stable and has a high concentration of active drug compared to existing commercial eye-drops. Two previous clinical studies using OCS-01 showed that it is safe and effective at improving vision and eye health, and is well-tolerated.
Participants will be involved in Stage 2 of the study for 52 weeks. They will be randomised to 1 of 2 groups, receiving either OCS-01 or a placebo in the affected eye 6 times a day for the first 6 weeks, then 3 times a day until Week 52. To be eligible, individuals must be between 18 and 85 with DME caused by diabetes mellitus type 1 or 2, and have not received previous treatment with anti-VEGF or corticosteroid intravitreally, or have done so more than a number of months prior to Day 1 of the study. Participants will undergo assessments testing eyesight and eye health, as well as but not limited to, blood tests, blood pressure measurement, medical history and pregnancy test if applicable. The study is taking place at NHS and private sites in the UK, as well as in a number of other countries. The Sponsor of this study is Oculis Operations Sarl.
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
24/NE/0018
Date of REC Opinion
15 Feb 2024
REC opinion
Further Information Unfavourable Opinion