Age-related macular degeneration
Conditions
Interventions
Ranibizumab (genetical recombination): Lucentis is 0.5 mg given monthly as a single intravitreal injection. This corresponds to an injection volume of 0.05 ml.Treatment is given consecutive 3 times e
Sponsors
Clinical Research Support Center Kyushu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with age-related macular degeneration accompanied by exudative change by FA, ICGA or OCT examination. 2) Best-corrected visual acuity (decimal point visual acuity) of subject eye is more than 0.05. 3) Both genders at more than 50 years old. 4) Patients providing written informed consent.
Exclusion criteria
Exclusion criteria: 1) Patients whose lesion site evaluated by FA examination is more than 12 optic disc areas (1 optic disc area is 30.5mm2, a lesion including a bleeding, scar and neo-vascularization) in subject eye. 2) Patient with a scar or fibrosis in the range more than 50% of all lesions in subject eye. 3) Patients with a history of retinal pigment epithelium tear or rupture in subject eye. 4) Patients with a history of more than stage 3 macular hole in subject eye. 5) Patients with treatment of triamcinolone intravitreal injection within 6 months in subject eye. 6) Patient with a history of intraocular surgical operation (including cataract) within 3 months in subject eye. 7) Patient with a history of surgical operation such as vitrectomy and submacular surgery in subject eye. 8) Patients with intraocular, extraocular and periocular inflammation or infectious in either eye. 9) Patients with a history of uveitis in either eye. 10) Patients with serious allergic history to such as fluoresceine, indocyanine green, iodo. 11) Women who have pregnancy, possibility of the pregnancy or are nursing. 12) Any other patients who are regarded as unsuitable for this study by the investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline change of best-corrected visual acuity (LogMAR) and QOL (VFQ-25) 3 months after ranibizumab administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Baseline change of best-corrected visual acuity (LogMAR) just before and 12 months after ranibizumab administration. 2) Baseline change of QOL (VFQ-25) just before and 12 months after ranibizumab administration. 3) Baseline change of central retinal thickness by OCT examination just before, 3 months and 12 months after ranibizumab administration. 4) Patient rate of exudative change (subretinal fluid, retinal edema and serous retinal pigment epithelial detachment) just before, 3 months and 12 months after ranibizumab administration. 5) Baseline change of greatest linear dimension just before, 3 months and 12 months after ranibizumab administration. 6) Baseline change of patient satisfaction questionnaire just before, 3 months and 12 months after ranibizumab administration. | — |
Countries
Japan
Contacts
Public ContactYuji Oshima
Kyushu University Graduate School of Medical Sciences Department of Ophthalmology
Outcome results
None listed