wetAMDPhase 2NCT07607561
Phase 2a Study to Evaluate the Efficacy and Safety of SCAI-005 Ophthalmic Solution in Subjects With Neovascular Age-related Macular Degeneration
A Phase 2 study testing SCAI-005 0.04% 2drops TID and SCAI-005 0.08% 2drops TID in people with wetAMD and Age Related Macular Degeneration, run by SCAI Therapeutics.
Trial summary
Trial to Evaluate the Safety and Efficacy of SCAI-005 Ophthalmic solution in Patients with Neovascular Age-related Macular Degeneration. The purpose of this study is to investigate the efficacy, safety and tolerability of SCAI-005 Ophthalmic solution by dose in patients with neovascular Age-related Macular… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- wetAMD, Age Related Macular Degeneration
- What is being tested?
- SCAI-005 0.04% 2drops TID and SCAI-005 0.08% 2drops TID
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 50 years or older
- Subjects who were diagnosed with nAMD in the study eye within 3 years prior to the Screening Visit, who demonstrated a treatment response to at least 3 repeated intravitreal injections of anti-VEGF IVT for nAMD, and whose last anti-VEGF IVT administration was more than 12 weeks prior to the planned date of the first administration of the investigational product.
- Active MNV secondary to nAMD with a subfoveal component related to the MNV activity in the study eye as assessed by FA (evidence of leakage) or SD-OCT (presence of fluid) at screening
- CST ≤ 450 μm at screening
- BCVA ETDRS letter score of 80 letters to 25 letters in the study eye as measured by the ETDRS visual acuity chart at screening
Who cannot join
- Subjects with choroidal neovascularization in the study eye due to causes other than nAMD (however, polypoidal choroidal vasculopathy (PCV) can be enrolled)
- Presence of scarring, fibrosis, or atrophy involving the fovea in the study eye at Screening
- Subjects who have a hemorrhage in the subfoveal region of the study eye and in whom the subretinal hemorrhage area is ≥ 1 optic disk area
- History of glaucoma surgery, vitrectomy, submacular surgery, or macular laser treatment (e.g., photodynamic therapy [PDT], laser photocoagulation, etc.) in the study eye
- Subjects with vitreous hemorrhage in the study eye
- History of ocular treatment (except for anti-VEGF IVT therapy), systemic treatment, or surgical intervention for the treatment of neovascular age-related macular degeneration (nAMD) in the study eye
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- Administration of intraocular, periocular, or intravitreal (IVT) steroid injection in the study eye within 24 weeks prior to Screening
- Presence of diabetic retinopathy, diabetic macular edema, or other vascular diseases affecting the retina, other than neovascular age-related macular degeneration (nAMD), in either eye
- History of endophthalmitis or idiopathic or autoimmune-related uveitis in either eye
- Subjects with active macular neovascularization identified in the fellow eye at Screening
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 Randomization, Double-blind, Placebo-controlled, Parallel, Multicenter, Phase 2a Study to Evaluate the Efficacy and Safety of SCAI-005 Ophthalmic Solution in Subjects With Neovascular Age-related Macular Degeneration
Trial to Evaluate the Safety and Efficacy of SCAI-005 Ophthalmic solution in Patients with Neovascular Age-related Macular Degeneration.
The purpose of this study is to investigate the efficacy, safety and tolerability of SCAI-005 Ophthalmic solution by dose in patients with neovascular Age-related Macular Degeneration (nAMD).
Read the detailed description
Subjects who have been informed about the study and have voluntarily agreed to sign to participate in the study will be screened.
Subjects who meet the inclusion/exclusion criteria will be randomized in 2:2:1 ratio into SCAI-005 0.04% and SCAI-005 0.08% and Placebo group.
Efficacy will be assessed at Weeks 4, 8, and 12. Safety and tolerability will be assessed until 12 weeks after randomization.
- Conditions
- wetAMD, Age Related Macular Degeneration
- Being tested
- SCAI-005 0.04% 2drops TID, SCAI-005 0.08% 2drops TID, Placebo 2drops TID
- Keywords
- wetAMD, CNV, eyedrop, TKI, Axitinib, Phase2
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCAI-005 0.04% 2drops TIDDrug
Axitinib 0.084mg/day
SCAI-005 0.08% 2drops TIDDrug
Axinitib 0.168mg/day
Placebo 2drops TIDDrug
vehicle
| Study group | Role | What they receive |
|---|---|---|
| SCAI-005 0.04% | Experimental | Not described Receives: Drug: SCAI-005 0.04% 2drops TID |
| SCAI-005 0.08% | Experimental | Not described Receives: Drug: SCAI-005 0.08% 2drops TID |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo 2drops TID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Central Subfield Thickness
measured by SD-OCT
Measured: 12weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for wetAMDStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SCAI Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07607561
- Sponsor's protocol ID
- SCAI-005-201
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomization, Double-blind, Placebo-controlled, Parallel, Multicenter, Phase 2a Study to Evaluate the Efficacy and Safety of SCAI-005 Ophthalmic Solution in Subjects With Neovascular Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT07607561
- Acronym / sponsor ID
- SCAI-005-201
- Conditions
- wetAMD, Age Related Macular Degeneration
- Keywords
- wetAMD, CNV, eyedrop, TKI, Axitinib, Phase2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- SCAI TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 26 May 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.
Trial to Evaluate the Safety and Efficacy of SCAI-005 Ophthalmic solution in Patients with Neovascular Age-related Macular Degeneration.
The purpose of this study is to investigate the efficacy, safety and tolerability of SCAI-005 Ophthalmic solution by dose in patients with neovascular Age-related Macular Degeneration (nAMD).
Detailed description
Subjects who have been informed about the study and have voluntarily agreed to sign to participate in the study will be screened.
Subjects who meet the inclusion/exclusion criteria will be randomized in 2:2:1 ratio into SCAI-005 0.04% and SCAI-005 0.08% and Placebo group.
Efficacy will be assessed at Weeks 4, 8, and 12. Safety and tolerability will be assessed until 12 weeks after randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SCAI-005 0.04% | Experimental | Drug: SCAI-005 0.04% 2drops TID |
| SCAI-005 0.08% | Experimental | Drug: SCAI-005 0.08% 2drops TID |
| Placebo | Placebo comparator | Drug: Placebo 2drops TID |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 50 years or older
- Subjects who were diagnosed with nAMD in the study eye within 3 years prior to the Screening Visit, who demonstrated a treatment response to at least 3 repeated intravitreal injections of anti-VEGF IVT for nAMD, and whose last anti-VEGF IVT administration was more than 12 weeks prior to the planned date of the first administration of the investigational product.
- Active MNV secondary to nAMD with a subfoveal component related to the MNV activity in the study eye as assessed by FA (evidence of leakage) or SD-OCT (presence of fluid) at screening
- CST ≤ 450 μm at screening
- BCVA ETDRS letter score of 80 letters to 25 letters in the study eye as measured by the ETDRS visual acuity chart at screening
Key exclusion criteria (10 listed)
- Subjects with choroidal neovascularization in the study eye due to causes other than nAMD (however, polypoidal choroidal vasculopathy (PCV) can be enrolled)
- Presence of scarring, fibrosis, or atrophy involving the fovea in the study eye at Screening
- Subjects who have a hemorrhage in the subfoveal region of the study eye and in whom the subretinal hemorrhage area is ≥ 1 optic disk area
- History of glaucoma surgery, vitrectomy, submacular surgery, or macular laser treatment (e.g., photodynamic therapy [PDT], laser photocoagulation, etc.) in the study eye
- Subjects with vitreous hemorrhage 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 |
|---|---|---|
| SCAI-005 0.04% 2drops TIDAxitinib 0.084mg/day | Drug | SCAI-005 0.04% |
| SCAI-005 0.08% 2drops TIDAxinitib 0.168mg/day | Drug | SCAI-005 0.08% |
| Placebo 2drops TIDvehicle | Drug | Placebo |
Primary outcome
Change in Central Subfield Thickness
Time frame: 12weeks
measured by SD-OCT
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 26 May 2026.
- Individual participant dataSharing planned: No
Related trials for wetAMD
Not yet recruitingPhase 1/2
First in Human Study of BETA-TT8 in wetAge-related Macular Degeneration (wetAMD)
Neovascular (Wet) Age-Related Macular Degeneration
Active, not recruitingPhase 3
Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD
AMD, nAMD
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SCAI-005 0.04% 2drops TID and SCAI-005 0.08% 2drops TID in people with wetAMD and Age Related Macular Degeneration, run by SCAI Therapeutics.
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Youjeong Heo (+82-42-867-0621, yheo@scaitrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Central Subfield Thickness (time frame: 12weeks). 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 26 May 2026.