Polypoidal Choroidal VasculopathyPhase 3PALLASNCT07389980
Prospective Trial of the Efficacy and Safety of a Personalized Regimen of High-dose Aflibercept 8mg on Treatment-naive Polypoidal Choroidal Vasculopathy: the PALLAS Trial
A Phase 3 study testing aflibercept 8 mg in people with Polypoidal Choroidal Vasculopathy and Polypoidal Choroidal Vasculopathy (PCV), run by Yeungnam University College of Medicine at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of the aflibercept 8 mg used in a personalized regimen, with flexible loading dose and treatment intervals from 8 to 24 weeks in eyes with treatment-naive PCV. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Polypoidal Choroidal Vasculopathy, Polypoidal Choroidal Vasculopathy (PCV)
- What is being tested?
- aflibercept 8 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Dec 2026to Dec 2028
- Phase
- Phase 3
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent must be obtained prior to participation in the study.
- Male or female patients ≥ 19 years of age at screening
- Presence of active polypoidal lesions in the macular as shown by ICGA and presence of serosanguinous maculopathy (exudative or hemorrhagic features involving the macula on floor fundus photography, FA and SD-OCT AND presence of IRF or SRF that affects the central subfield as seen by SD-OCT
- Best-corrected visual acuity (BCVA) score between 83 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at both screening and baseline visit (study eye)
Who cannot join
- Ocular conditions/disorders at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the first 12-month study period, structural damage of the fovea, atrophy or fibrosis at the center of the fovea (study eye)
- A history of any evidence of type 2 or type 3 neovascularization, myopic choroidal neovascularization, or other ocular disorders
- Total area of subretinal hemorrhage larger than 9DA or comprising ≥ 50% of the lesion area or presence of vitreous hemorrhage in study eye
- Any active intraocular or periocular infection or active intraocular inflammation, at screening or baseline (study eye)
- Uncontrolled glaucoma defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to investigator's judgment, at screening or baseline (study eye)
- Ocular treatments: any anti-VEGF drugs, intraocular or periocular steroids, macular laser photocoagulation or PDT, previous ocular surgery except cataract surgery (study eye)
- Stroke or myocardial infarction during the 6-month period prior to baseline
- Systemic anti-VEGF therapy at any time.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Yeungnam University Hospital
Daegu, 42415
Sohee Shin, 82-53-620-3440, ey005@ymc.yu.ac.kr
About this study
The purpose of this study is to evaluate the efficacy and safety of the aflibercept 8 mg used in a personalized regimen, with flexible loading dose and treatment intervals from 8 to 24 weeks in eyes with treatment-naive PCV.
- Being tested
- aflibercept 8 mg
- Keywords
- PCV, Polypoidal Choroidal Vasculopathy, PALLAS, Aflibercept 8 mg
- Medical subject headings
- Polypoidal Choroidal Vasculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aflibercept 8 mgDrug
The first loading injection will be performed for all participants. After 4 weeks, treatment response will be judged. If the polyp is completely regressed with no disease activity, injection interval will be extended to 8 weeks. The participants with presence of disease activity will continue 4-week loading injections up to 3 monthly loading dose and commence the T\&E phase thereafter. In the T\&E phase, patients have their injection interval extended or shortened by 4 weeks. The injection interval is maintained if the criteria for treatment adjustment were not met and residual fluid was decreased from the previous visit. The minimum and maximum injection intervals are 8 and 24 weeks, respectively.
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept 8 mg | Experimental | The first loading injection will be performed for all participants. After 4 weeks, treatment response will be judged. If the polyp is completely regressed with no disease activity, injection interval will be extended to 8 weeks. The participants with presence of disease activity will continue 4-week loading injections up to 3 monthly loading dose and commence the T\&E phase thereafter. In the T\&E phase, patients have their injection interval extended or shortened by 4 weeks. The injection interval is maintained if the criteria for treatment adjustment were not met and residual fluid was decreased from the previous visit. The minimum and maximum injection intervals are 8 and 24 weeks, respectively. Receives: Drug: aflibercept 8 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients who reached a treatment interval of ≥16 weeks at Week 96
Measured: Week 96
Secondary outcomes (4)
Last injection interval at week 96
Measured: Week 96
Best corrected visual acuity (BCVA) at weet 96
Measurement with the Early Treatment Diabetic Retinopathy Study (ETDRS) letters score
Measured: Week 96
Central retinal thickness and choroidal thickness at week 96
Average retinal thickness at the central 1 mm diameter
Measured: Week 96
umber of participants with treatment-related adverse events
Slit lamp examination and fundoscopy
Measured: Week 96
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start24 Dec 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polypoidal Choroidal VasculopathyStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yeungnam University College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Min Sagong, Yeungnam University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389980
- Sponsor's protocol ID
- 2025-10-050
- Acronym
- PALLAS
- Status last verified
- Jan 2026
- First submitted
- 23 Dec 2025
- Last updated
- 5 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Trial of the Efficacy and Safety of a Personalized Regimen of High-dose Aflibercept 8mg on Treatment-naive Polypoidal Choroidal Vasculopathy: the PALLAS Trial
- ClinicalTrials.gov ID
- NCT07389980
- Acronym / sponsor ID
- PALLAS / 2025-10-050
- Keywords
- PCV, Polypoidal Choroidal Vasculopathy, PALLAS, Aflibercept 8 mg
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yeungnam University College of MedicineUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 24 Dec 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 5 Feb 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 purpose of this study is to evaluate the efficacy and safety of the aflibercept 8 mg used in a personalized regimen, with flexible loading dose and treatment intervals from 8 to 24 weeks in eyes with treatment-naive PCV.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept 8 mg | Experimental | Drug: aflibercept 8 mgThe first loading injection will be performed for all participants. After 4 weeks, treatment response will be judged. If the polyp is completely regressed with no disease activity, injection interval will be extended to 8 weeks. The participants with presence of disease activity will continue 4-week loading injections up to 3 monthly loading dose and commence the T\&E phase thereafter. In the T\&E phase, patients have their injection interval extended or shortened by 4 weeks. The injection interval is maintained if the criteria for treatment adjustment were not met and residual fluid was decreased from the previous visit. The minimum and maximum injection intervals are 8 and 24 weeks, respectively. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed informed consent must be obtained prior to participation in the study.
- Male or female patients ≥ 19 years of age at screening
- Presence of active polypoidal lesions in the macular as shown by ICGA and presence of serosanguinous maculopathy (exudative or hemorrhagic features involving the macula on floor fundus photography, FA and SD-OCT AND presence of IRF or SRF that affects the central subfield as seen by SD-OCT
- Best-corrected visual acuity (BCVA) score between 83 and 23 letters, inclusive, using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts at both screening and baseline visit (study eye)
Key exclusion criteria (8 listed)
- Ocular conditions/disorders at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require planned medical or surgical intervention during the first 12-month study period, structural damage of the fovea, atrophy or fibrosis at the center of the fovea (study eye)
- A history of any evidence of type 2 or type 3 neovascularization, myopic choroidal neovascularization, or other ocular disorders
- Total area of subretinal hemorrhage larger than 9DA or comprising ≥ 50% of the lesion area or presence of vitreous hemorrhage in study eye
- Any active intraocular or periocular infection or active intraocular inflammation, at screening or baseline (study eye)
- Uncontrolled glaucoma defined as intraocular pressure (IOP) > 25 mmHg on medication, or according to investigator's judgment, at screening or baseline (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 |
|---|---|---|
| aflibercept 8 mgThe first loading injection will be performed for all participants. After 4 weeks, treatment response will be judged. If the polyp is completely regressed with no disease activity, injection interval will be extended to 8 weeks. The participants with presence of disease activity will continue 4-week loading injections up to 3 monthly loading dose and commence the T\&E phase thereafter. In the T\&E phase, patients have their injection interval extended or shortened by 4 weeks. The injection interval is maintained if the criteria for treatment adjustment were not met and residual fluid was decreased from the previous visit. The minimum and maximum injection intervals are 8 and 24 weeks, respectively. | Drug | Aflibercept 8 mg |
Primary outcome
The proportion of patients who reached a treatment interval of ≥16 weeks at Week 96
Time frame: Week 96
4 secondary outcomes
Last injection interval at week 96
Time frame: Week 96
Best corrected visual acuity (BCVA) at weet 96
Time frame: Week 96
Central retinal thickness and choroidal thickness at week 96
Time frame: Week 96
umber of participants with treatment-related adverse events
Time frame: Week 96
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 5 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing aflibercept 8 mg in people with Polypoidal Choroidal Vasculopathy and Polypoidal Choroidal Vasculopathy (PCV), run by Yeungnam University College of Medicine at 1 site in South Korea.
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 4 inclusion and 8 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 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Sohee Shin (82-53-620-3440, ey005@ymc.yu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients who reached a treatment interval of ≥16 weeks at Week 96 (time frame: Week 96). 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 5 Feb 2026.