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. at 2 sites in United States.
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
- 2 sitesUnited States
- Study dates
- 1 Jul 2026to 23 Aug 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Valley Retina Institute, P.A.
McAllen, Texas, 78503
- Recruiting
Macula and Vitreous Center
Torrance, California, 90503
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
- 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
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07557121
- Acronym / sponsor ID
- AIV007-E03
- Keywords
- wet AMD, anti-VEGF, periocular, Eylea, tyrosine kinase inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- AiViva BioPharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- ClinDatrix, Inc.
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 23 Aug 2027 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Part 1 Single AIV007 Dose Multicenter, Randomized, Active-controlled Trial Part 2 Open-Label Repeat AIV007 Dose
| Arm | Type | Receives |
|---|---|---|
| Group 1: AIV007 | Experimental | Drug: AIV007 |
| Group 2: AIV007 | Experimental | Drug: AIV007 |
| Group 3: Eylea | Active comparator | Biological: EYLEA® (aflibercept) Injection 2 mg (0.05mL) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIV0076 mg or 8 mg dose | Drug | Group 1: AIV007, Group 2: AIV007 |
| EYLEA® (aflibercept) Injection 2 mg (0.05mL)Eylea 2 mg, marketed product | Biological | Group 3: Eylea |
Primary outcome
Best-corrected Visual Acuity
Time frame: Month 6
Mean change from baseline in best-corrected visual acuity using ETDRS Charts
1 secondary outcome
Durability
Time frame: Month 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Darlene C. Deecher, phd (2674544560, darlene@aiviva.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best-corrected Visual Acuity (time frame: Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.