Neovascular (Wet) Age-Related Macular DegenerationPhase 2NCT07557121
Safety and Efficacy of AIV007 Periocular Injection in Patients With Neovascular Age-Related Macular Degeneration
A Phase 2 study testing AIV007 and EYLEA® (aflibercept) Injection 2 mg (0.05mL) in people with Neovascular (Wet) Age-Related Macular Degeneration, run by AiViva BioPharma, Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Neovascular (Wet) Age-Related Macular Degeneration
- What is being tested?
- AIV007 and EYLEA® (aflibercept) Injection 2 mg (0.05mL)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2026to 23 Aug 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the 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:
- Does AIV007 have an acceptable safety profile?
- Does AIV007 maintain or improve best corrected visual acuity?
- Does AIV007 sustain or decrease central subfield thickness?
- 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.
- Being tested
- AIV007, EYLEA® (aflibercept) Injection 2 mg (0.05mL)
- Keywords
- wet AMD, anti-VEGF, periocular, Eylea, tyrosine kinase inhibitor
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIV007Drug
6 mg or 8 mg dose
EYLEA® (aflibercept) Injection 2 mg (0.05mL)Biological
Eylea 2 mg, marketed product
| Study group | Role | What they receive |
|---|---|---|
| Group 1: AIV007 | Experimental | Not described Receives: Drug: AIV007 |
| Group 2: AIV007 | Experimental | Not described Receives: Drug: AIV007 |
| Group 3: Eylea | Active comparator | Not described Receives: Biological: EYLEA® (aflibercept) Injection 2 mg (0.05mL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best-corrected Visual Acuity
Mean change from baseline in best-corrected visual acuity using ETDRS Charts
Measured: Month 6
Secondary outcomes (1)
Durability
Proportion of participants that did not require supplemental medication
Measured: Month 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion23 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular (Wet) Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Part 1 Single AIV007 Dose Multicenter, Randomized, Active-controlled Trial Part 2 Open-Label Repeat AIV007 Dose
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AiViva BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinDatrix, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557121
- Sponsor's protocol ID
- AIV007-E03
- Status last verified
- Apr 2026
- First submitted
- 23 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided