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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).
PDT with verteporfin has been proven beneficial for patients with AMD. The laser spot size is decided based on FA finding (FA guided PDT). ICGA is needed to detect PCV lesions, such as polypoidal lesions or abnormal network vessels. In clinical practice, PDT based on ICGA (ICGA guided PDT) has and is being conducted for the treatment of AMD with PCV. However, there are no reports on the outcomes of prospective research of PDT for PCV in Japanese patients. Furthermore, there are no reports comparing FA guided PDT and ICGA guided PDT.
We propose to conduct this clinical research in order to investigate the efficacy and safety of PDT for PCV in Japanese patients, and to compare results of FA guided PDT and ICGA guided PDT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | FA-guided PDT |
|
| 2 | Experimental | ICG-guided PDT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocular photodynamic therapy with verteporfin | Procedure | Ocular photodynamic therapy with 6 mg per meter squar of body sarface of verteporfin with PDT lazer application for 83 seconds |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of number of study eyes which BCVA improves 3 lines or more or maintains (+/-1 line), as compared with baseline examination. | 12 month | |
| Factor affecting to change in visual acuity. | 12month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomohiro Iida, MD | Ophthalmic PDT Study Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya City University Hospital | Aichi | Japan | ||||
| Nagoya University |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077362 | Verteporfin |
| D010778 | Photochemotherapy |
| ID | Term |
|---|---|
| D011166 | Porphyrins |
| D045725 | Tetrapyrroles |
| D011758 | Pyrroles |
| D001393 | Azoles |
| D006573 |
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|
| Proportion of eyes with decimal BCVA of 0.5 or more. | 12 month |
| Change of findings of polypoidal lesions. | 0-12 month |
| Change of findings of abnormal network vessels. | 0-12 month |
| Change in greatest linear dimension (GLD) based on FA. | 0-12 month |
| PCV lesion size based on ICGA. | 0-12 month |
| Choroidal neovascularization (CNV) closure based on FA. | 0-12 month |
| Change in subretinal fluid at the fovea and central retinal thickness based on optical coherence tomography (OCT). | 0-12month |
| Mean number of PDT treatments required during the study period. | 12 month |
| Aichi |
| Japan |
| Kyushu University | Fukuoka | 812-0054 | Japan |
| Fukushima Medical University School of Medicine | Fukushima | 960-1295 | Japan |
| Gunma University | Gunma | Japan |
| Kagawa University | Kagawa | 761-0793 | Japan |
| Kyoto University | Kyoto | 606-8507 | Japan |
| Osaka University | Osaka | 565-0871 | Japan |
| Kansai Medical University Takii Hospital | Osaka | 570-8507 | Japan |
| Kansai Medical University Hirakata Hospital | Osaka | 573-1191 | Japan |
| Sapporo City general hospital | Sapporo | 060-8604 | Japan |
| Shiga University of Medical Science | Shiga | Japan |
| Surugadai Nihon University Hospital | Tokyo | 101-8309 | Japan |
| Kyorin University | Tokyo | 181-8611 | Japan |
| Toho University | Tokyo | Japan |
| Tokyo University Ohashi Medical Center | Tokyo | Japan |
| Yamanashi University | Yamanashi | Japan |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D010789 | Phototherapy |