Age related macular degeneration MedDRA version: 9.1 Level: LLT Classification code 10064930 Term: Age-related macular degeneration
Conditions
Interventions
Trade Name: Dexamethasone
Product Name: Dexamethasone
Pharmaceutical Form: Solution for injection
INN or Proposed INN: DEXAMETHASONE SODIUM PHOSPHATE
CAS Number: 2392394
Concentration unit: mg/ml mill
Sponsors
Kings College Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 on fluorescein angiography. 6. Log MAR best corrected visual acuity of 24-73 letters on EDTRS chart Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 > -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 utilized 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and effectiveness of the combined therapy of intravitreal ranubizumab/ dexamethasone , oral minocycline and verteporfin photodynamic therapy for subfoveal choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD).;Secondary Objective: ;Primary end point(s): Primary Endpoint • Evaluate the changes in visual acuity from baseline at 12 months in patients treated with intravitreal ranibizumab in combination with verteporfin photodynamic therapy. | — |
Countries
United Kingdom
Outcome results
None listed