Bevacizumab Safety for Retinal Disease
(NORSE SEVEN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety of bevacizumab (an injection) for individuals with certain eye conditions. It compares two delivery methods: vials and pre-filled syringes. The trial targets those diagnosed with specific retinal issues, such as wet age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion, who require eye injections. Candidates who haven't used similar treatments in the past month and haven't undergone certain eye procedures or conditions may qualify. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment option.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot have used certain eye treatments like anti-VEGF or Avastin® within 4 weeks before joining. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that bevacizumab is safe for treating various eye conditions, including age-related macular degeneration and diabetic eye disease. Studies have found that bevacizumab works effectively and is generally safe for these conditions. However, some reports have noted complications, such as retinal detachment, following its injection.
Other studies have found that bevacizumab is relatively safe compared to similar treatments. Overall, bevacizumab is considered safe and well-tolerated for many patients with eye issues. Discussing any potential risks with a healthcare provider is always important.12345Why do researchers think this study treatment might be promising?
Bevacizumab is unique because it offers a targeted approach to treating retinal diseases by inhibiting a protein called VEGF, which is responsible for the abnormal blood vessel growth that can damage the retina. Unlike standard treatments like laser therapy or other anti-VEGF drugs such as ranibizumab and aflibercept, bevacizumab is often considered cost-effective while potentially providing similar efficacy. Researchers are excited about bevacizumab because it might offer a more accessible and affordable option for patients, without compromising on effectiveness. This could significantly broaden treatment access and improve outcomes for individuals with retinal diseases.
What is the effectiveness track record for bevacizumab in treating retinal conditions?
Research has shown that bevacizumab helps treat various eye conditions. For individuals with diabetic macular edema, it can improve vision by about seven letters on an eye chart over a year. Those with age-related macular degeneration who use bevacizumab maintain clearer vision for five years compared to other treatments. Studies also indicate that bevacizumab and similar drugs are safe for managing diabetic macular edema. Overall, strong evidence supports bevacizumab's ability to improve vision in these conditions.36789
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intravitreal injections of bevacizumab in vials or pre-filled syringes
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- bevacizumab
Find a Clinic Near You
Who Is Running the Clinical Trial?
Outlook Therapeutics, Inc.
Lead Sponsor