The goal of this study is to evaluate whether AIV007 provides benefits to patients with neovascular age-related macular degeneration in improving vision and that it has an acceptable safety profile. Participants will receive either a periocular injection of AIV007 or intravitreal injection of Eylea (control arm) to the study eye and return to the clinic monthly for safety and how well it works observations and/or continued treatment.
Official registry: https://clinicaltrials.gov/study/NCT07557121 · AiViva BioPharma, Inc. · enrollment listed as 35
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
If you join, the listed intervention(s) are AIV007, or EYLEA® (aflibercept) Injection 2 mg (0.05mL). The registry lists allocation as randomized. The goal of this study is to evaluate whether AIV007 provides benefits to patients with neovascular age-related macular degeneration in improving vision and that it has an acceptable safety profile.
They plan to enroll about 35 people at 2 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic plus check-ins.
A Phase 2, Multicenter, Randomized, Active-controlled Trial of the Safety and Efficacy of AIV007 by Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
Interventions: AIV007, EYLEA® (aflibercept) Injection 2 mg (0.05mL)
Primary outcome (registry wording): Best-corrected Visual Acuity
Darlene C. Deecher, phd
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Background: \- Best Vitelliform Dystrophy (Best disease), Late-Onset Retinal Degeneration (L-ORD), and Age-Related Macular Degeneration (AMD) all affect the retina, the light sensing area at the back of the eye. Doctors cannot safely obtain retinal cells to study these diseases.
NCT01432847 · Official ClinicalTrials.gov record · National Eye Institute (NEI)
Background: \- To understand diseases of the retina and the eye, information is needed about people with and without such diseases. Researchers want to study these people and follow them over time.
NCT01496625 · Official ClinicalTrials.gov record · National Eye Institute (NEI)
This study will measure the long-term whether it is safe and how hard side effects are to live with of the Port Delivery System with ranibizumab (PDS) (100 mg/mL) in participants with neovascular age-related macular degeneration (nAMD) who have either completed Phase II Study GX28228 (Ladder), Phase III Study GR40548 (Archway), Phase IIIb Study WR42221 (Velodrome), or completed Week 24 visit in Study WR42221 but were not eligible to be randomly assigned in WR42221.
NCT03683251 · Official ClinicalTrials.gov record · Hoffmann-La Roche
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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