Bevacizumab Safety for Retinal Disease

(NORSE SEVEN Trial)

Recruiting at 2 trial locations

Overseen By Jennifer M Kissner, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Outlook Therapeutics, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The study will compare the safety of ophthalmic bevacizumab in vials versus pre-filled syringes in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.

Eligibility Criteria

This trial is for individuals with certain retinal disorders like wet age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion. Participants must need anti-VEGF therapy and not have used similar treatments recently. They shouldn't have other eye conditions that could affect the study or be premenopausal women without contraception.

Inclusion Criteria

I have AMD, DME, or BRVO confirmed by OCT and need anti-VEGF therapy.

Exclusion Criteria

I have bleeding inside the eye being studied.

I have active inflammation in my eye.

I have an eye condition that might get worse or need treatment during the study.

Treatment Details

Interventions

• bevacizumab (Monoclonal Antibodies)

Trial Overview The safety of an eye medication called bevacizumab is being tested in two forms: vials and pre-filled syringes. The drug will be given through injections into the eye to people with specific vision impairments due to retinal diseases.

Participant Groups

Group I: Biological: bevacizumab Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Outlook Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

1,000+