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New combo therapy shows promise for blinding eye condition
NCT ID NCT03941587
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two treatments for polypoidal choroidal vasculopathy (PCV), an eye disease that can lead to blindness. Sixty patients received either eye injections of aflibercept alone or aflibercept combined with a special light therapy (reduced-fluence PDT). The goal was to see which approach better closed abnormal blood vessels and improved vision over 12 weeks.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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60 people
The number who actually took part.
- Started
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Feb 2021
- Finished
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Jun 2024
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients aged over 50 years old at the time of informed consent. * Provide written informed consent. * Willingness and ability to comply with all scheduled visits and study procedures. * Confirmed diagnosis of symptomatic macular PCV based ICGA. * Activity of PCV confirmed by exudative activity involving the macula on OCT or Fluorescein Angiography (FA) or both. * Presence of intra retinal or subretinal fluid/blood as seen on OCT * Treatment naïve * NO previous treatment with intravitreal anti-VEGF agents, regardless of the indication * NO previous thermal laser in the macular region, or verteporfin photodynamic therapy (vPDT), regardless of indication * NO other previous treatment for neovascular AMD (nAMD), except oral supplements and traditional Chinese medicine * An ETDRS BCVA of at least 4 letters (Snellen equivalent approximately 20/800 or better) in the study eye. * Greatest Linear Dimension (GLD) of the total lesion area (BVN + polyps) \<5400µm (\~9 mucopolysaccharidoses (MPS) Disc Areas) as delineated by ICGA. Exclusion Criteria: - Participant * Medical condition that, in the opinion of the investigator, would preclude participation in the study (e.g. unstable medical status including blood pressure, cardiovascular disease, and glycemic control). * Participation in an investigational trial within 30 days of enrollment which involves treatment with unapproved investigational drug. * Known allergy to any component of the study drug. * Blood pressure\> 180/110 (systolic above 180 OR diastolic above 110 on repeated measurements). If blood pressure is brought below 180/110 by anti-hypertensive treatment, individual can become eligible. * Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization. * Systemic anti-VEGF or pro-VEGF treatment within four months prior to randomization or anticipated use during the study. * Amblyopia or blind in one eye Study Eye * Eye with intra retinal or sub-retinal fluid due to other causes than PCV * An ocular condition is present (other than PCV) that, in the opinion of the investigator, might affect intra or sub retinal fluid or alter visual acuity during the course of the study (e.g., Diabetic Macular Edema (DME), vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.) * Substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by more than three lines (i.e., cataract would be reducing acuity to worse than 20/40 if eye was otherwise normal). * Any intraocular surgery within 1 month of enrollment * Treatment with intra vitreal corticosteroids * History of retinal detachment or surgery for retinal detachment * History of vitrectomy * History of macular hole * Evidence of vitreomacular traction that may preclude resolution of macular edema \> 4 disc areas of intra/sub retinal hemorrhage * Aphakia * Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis Other Eye * Active intraocular inflammation * History of uveitis
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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National University Hospital
Singapore, Singapore
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Singapore National Eye Centre
Singapore, Singapore, 168751, Singapore
More trials for these conditions
Other studies related to the condition(s) this trial covers.