ISRCTN34410935Completed未知
A pilot study to examine the safety and efficacy of intravitreal ranubizumab/dexamethasone administration and oral minocycline in addition to Visudyne (verteporfin) photodynamic therapy for subfoveal choroidal neovascularization secondary to age-related macular degeneration: an open-label trial
King's College Hospital NHS Foundation Trust (UK)0 sites20 target enrollmentStarted: May 30, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. The patient must be willing to give written informed consent
- •2. The patient must be able to undertake the necessary tests and treatment and be willing to be followed up
- •3. Age 50 years or older
- •4. Clinical diagnosis of AMD
- •5. Subfoveal CNV confirmed by fluorescein angiography
- •6. Logarithmic minimal angle of resolution (LogMAR) best corrected visual acuity of 24 - 73 letters on early treatment diabetic retinopathy study (ETDRS) chart
Exclusion Criteria
- •1. Inability to understand or sign consent form
- •2. The patient has a current medical condition or history of a medical condition that would be likely to preclude scheduled study visits such as unstable angina, dialysis, and active cancer
- •3. Patient has a current ophthalmic condition or history of an ophthalmic condition that might compromise the assessment of the treatment such as diabetic retinopathy, uveitis, amblyopia, ischaemic optic neuropathy
- •4. Signs of a myopic retina or refraction of greater than -8 dioptres in their current or any previous glasses prescription
- •5. Signs of other retinal conditions that may have caused the CNV such as angioid streaks, choroidal rupture, and old chorio-retinitis
- •6. Open angle glaucoma
- •7. At increased risk of developing glaucoma such as having pigment dispersion syndrome or pseudoexfoliation
- •8. Unable to have a good quality fluorescein angiogram taken, e.g., due to head tremor or media opacity
- •9. Known hypersensitivity to fluorescein or any of the study medications
- •10. Previous treatment for a retinal detachment
- •11. Judged by the examining clinician to be at increased risk of retinal detachment due to weaknesses in the peripheral retina
- •12. Previous photodynamic therapy or other therapy for a CNV including argon laser treatment
- •13. Patient is currently participating or has participated in a clinical trial that utilised an investigational drug or treatment within 30 days prior to enrolment to this study
- •14. On anticoagulation therapy such as warfarin, with the exception of aspirin and other anti-platelet therapy
- •15. Exclusion of women of childbearing potential
- •16. Exclusion of pregnant or lactating women
Investigators
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