Age-related macular degeneration Eye Diseases Age-related macular degeneration
Conditions
Interventions
Patients will receive a reduced light dose (25 J/cm^2) verteporfin photodynamic therapy, and an intravitreal injection of 0.3 mg ranibizumab and 200 µg dexamethasone at their first visit. Minocycline
Sponsors
King's College Hospital NHS Foundation Trust (UK)
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 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the changes in visual acuity from baseline at 12 months in patients treated with intravitreal ranibizumab in combination with verteporfin photodynamic therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mean change from baseline in best corrected visual acuity (BCVA) at month six 2. Proportion of patients who gain greater than or equal to 5, 10, 15 letters of BCVA from baseline at months 6 and 12 3. Proportion of patients who lose less than 15 letters of BCVA from baseline at months 6 and 12 4. Mean change from baseline in total size of lesion and total size of CNV at 3, 6, and 12 months 5. Change in area of leakage at 3, 6 and 12 months 6. Total number of treatments of Lucentis 7. Mean time to first re-treatment following the initial combination therapy 8. Mean change in retinal lesion thickness by optical coherence tomography (OCT) at centre of fovea at 3, 6, and 12 months | — |
Countries
United Kingdom
Outcome results
None listed