Neovascular (Wet) Age-Related Macular Degeneration
Conditions
Keywords
wet AMD, anti-VEGF, periocular, Eylea, tyrosine kinase inhibitor
Brief summary
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 efficacy observations and/or continued treatment. Participants may receive additional treatment(s) if they meet specified criteria.
Detailed description
This study will have 2 parts. In Part 1, participants will randomized to receive either AIV007 (6 or 8 mg) or standard of care in a masked fashion and followed for 6 months. The main questions to be answered are: 1. Does AIV007 have an acceptable safety profile? 2. Does AIV007 maintain or improve best corrected visual acuity? 3. Does AIV007 sustain or decrease central subfield thickness? 4. Does AIV007 provide a long duration of effect greater than or equal to 5 months? In Part 2, eligible participants will receive a second injection of AIV007 in an open-labeled design to assess safety and efficacy of repeat doses.
Interventions
DRUGAIV007
6 mg or 8 mg dose
Eylea 2 mg, marketed product
Sponsors
AiViva BioPharma, Inc.
ClinDatrix, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Central Reading Center, Sub-PI, BCVA technicans
Intervention model description
Part 1 Single AIV007 Dose Multicenter, Randomized, Active-controlled Trial Part 2 Open-Label Repeat AIV007 Dose
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Previously treated neovascular (wet) age-related macular degeneration (nAMD) * Responsive to prior intravitreal anti-VEGF therapy * Study eye at screening must have an ETDRS letter score greater than 35 (20/200 Snellen equivalent) * Active choroidal neovascularization lesion in the study eye secondary to nAMD. * Central subfield thickness in the study eye of less than or equal to 370 microns. * Compliance to all study protocol requirements
Exclusion criteria
* Study eye has had previous treatment with cell therapy, brachytherapy, and/or gene therapy * History of uncontrolled intraocular pressure * Presence of any clinically significant epiretinal membrane, vitreomacular traction, subfoveal atrophy (including RPE degeneration), RPE tear in the study eye * History of vitreoretinal surgery, corneal transplant, glaucoma surgery in the study eye or cataract surgery within 3 months before screening visit * History of vitreous hemorrhage within 3 months prior to screening visit in the study eye * A clinically significant cataract (including PSC) likely to affect trial outcomes (i.e., vision) in the study eye * Anterior chamber intraocular lens, aphakia, or violation of the posterior capsule in the study eye; prior Nd:YAG laser posterior capsulotomy in association with posterior intraocular lens implantation is allowed provided it occurred at least 30 days before the screening visit * Any active bacterial, viral, fungal or parasitic ocular or periocular infection or any history of uveitis in either eye * Intraretinal fluid (IRF) in the proposed study eye of less than 30 µm confirmed by the CRC following the screening visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Best-corrected Visual Acuity | Month 6 | Mean change from baseline in best-corrected visual acuity using ETDRS Charts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Durability | Month 5 | Proportion of participants that did not require supplemental medication |
Contacts
CONTACTDarlene C. Deecher, phd
CONTACTDiane DS Tang-Liu, PHD
Outcome results
None listed