Bevacizumab Safety for Retinal Disease

(NORSE SEVEN Trial)

Recruiting at 2 trial locations

Overseen By Jennifer M Kissner, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Outlook Therapeutics, Inc.

Must be taking: Anti-VEGF therapy

Must not be taking: Anti-VEGF, Corticosteroids

Disqualifiers: Intraocular inflammation, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: Unknown

120 Participants Needed

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

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+