Semaglutide for Diabetic Eye Disease

(FOCUS Trial)

Recruiting at320 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novo Nordisk A/S

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study will look at the long-term effects of semaglutide (active medicine) on diabetic eye disease when compared to placebo (dummy medicine). The study will be performed in people with type 2 diabetes. Participants will either get semaglutide or placebo in addition to their diabetes medicines - which treatment the participant gets is decided by chance. Participants will inject the study medicine using a pen-injector. The medicine must be injected in a skin fold in the stomach, thigh or upper arm once a week. The study will last for 5 years.

Research Team

Clinical Reporting Anchor and Disclosure (1452)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

Adults with type 2 diabetes and moderate diabetic eye disease, who haven't had certain eye treatments or conditions that could affect the study. They should have an HbA1c level between 7.0-10.0% and not be on any GLP-1 receptor agonists or DPP-4 inhibitors from randomisation.

Inclusion Criteria

I haven't had eye treatments for diabetes-related conditions in the last 6 months.

Your HbA1c level is between 7.0% and 10.0%.

My eyes are healthy except for diabetes-related issues.

Exclusion Criteria

I am scheduled for a procedure to improve blood flow to my heart, neck, or limbs.

My kidney function is low, with an eGFR under 30.

Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol

Treatment Details

Interventions

• Placebo (semaglutide) (Drug)
• Semaglutide (Glucagon-like peptide-1 receptor agonist)

Trial Overview The trial is testing if semaglutide can help diabetic eye disease compared to a placebo over five years. Participants will inject either semaglutide or placebo once a week alongside their regular diabetes medication.

Participant Groups

Group I: Semaglutide Experimental Treatment 1 Intervention

Participants will receive semaglutide once weekly as subcutaneous (s.c., under the skin) injection added to standard of care.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo (semaglutide) once weekly as subcutaneous subcutaneous (s.c., under the skin) injection added to standard of care.

Semaglutide is already approved in Canada, Japan for the following indications:

Approved in Canada as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Approved in Japan as Ozempic for:

• Type 2 diabetes
• Cardiovascular disease
• Obesity

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials

1,578

Recruited

3,813,000+

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen