CompletedPhase 4

PDT Study for Exudative AMD With PCV

Japan113 participantsStarted 2006-06

Plain-language summary

The purpose of this study is to evaluate and conduct an exploratory comparison of the efficacy and safety of indocyanine green angiography (ICGA) guided photodynamic therapy (PDT) and fluorescein angiography (FA) guided PDT for exudative age-related macular degeneration (AMD) accompanied with polypoidal choroidal vasculopathy (PCV).

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Japanese patients aged 50 years old or older * Exudative AMD with subfoveal PCV * Eyes with PCV meets the definite criteria of PCV issued from Japanese study group of Polypoidal Choroidal Vasculopathy * PCV lesion with subfoveal hemorrhage or exudation * Lesion size (GLD) of less than 12 MPS Disc area measured by FA and IA. * Decimal BCVA of 0.1-0.5 at baseline period. Exclusion Criteria: * Patients who have RPE tear, vitelliform retinal dystrophy, and central Serous Chorioretinopathy. * Patients who have other ocular disease with irreversible VA * Study eyes unable to be taken fundus photos of CNV * Study eyes received surgery operation within 2 months of the participation to this study or ND:YAG operation within one month * Pathological myopia * PCV with cleary identified subsensory retinal CNV (on the RPE) at the baseline examination * Study eyes which have received any treatments for CNV, such as PDT, transpupillary thermotherapy, laser photocoagulation, and so on. * Patients who have any physical problem for using angiography or PDT (such as systemic debility, significant diabetes mellitus, significant heart disease, and so on) * Medical history of porphyria, porphyrin sensitivity, or hypersensitivity to sunlight or bright light. * Patients with medical history of hypersensitivity to ingredients of Visudyne * Patients with medical history of hypersensitivity to ingredients of fluorescein or indocyanine green injection * Patients with hypersensiti…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of study eyes which best corrected visual acuity (BCVA) improves 2 lines or more or maintains (+/-1 line changes) at 12 months after first treatment, as compared with the visual acuity at baseline period.

Timeframe: 12 months

Trial details

NCT IDNCT00331435

SponsorOphthalmic PDT Study Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-01

View on ClinicalTrials.gov More Age Related Macular Degeneration trials