Choroidal neovascularization (CNV) secondary to Age-related macular degeneration (AMD) Eye Diseases Macular degeneration
Conditions
Interventions
1. Posterior juxta-scleral (40 mg) triamcinolone acetonide + verteporfin photodynamic therapy
2. Intra-vitreal (4 mg) triamcinolone acetonide + verteporfin photodynamic therapy
3. Verteporfin photodyn
Sponsors
The Newcastle upon Tyne Hospitals NHS 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. Predominantly classic CNV on fluorescein angiography 6. Logarithm of the minimum angle of resolution (LogMAR) visual acuity of >35 letters on 2 m Early Treatment Diabetic Retinopathy Study (ETDRS) chart 7. Does not have open angle glaucoma
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, 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 diopters in their current or any previous glasses prescription 5. Signs of other retinal conditions that may have caused the CNV such as angiod streaks, choroidal rupture, 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. Allergic to fluorescein or verteporfin or triamcinolone acetonide 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. <35 letters on the ETDRS logMAR chart 16. Inability to read a logMAR chart 17. Intraocular surgery in study eye within 60 days prior to planned enrolment in study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of patients losing more than 15 letters (3 lines) of visual acuity (ETDRS logMAR chart at 2m) at 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in lesion size at one year 2. Number of re-treatments required in one year 3. Incidence of serious complications 4. Quality of life measures: NEIVFQ(25); SF-36 5. Contrast sensitivity threshold (Pelli-Robson contrast sensitivity chart) 6. Change in retinal thickness as shown on Ocular coherence tomography | — |
Countries
United Kingdom
Outcome results
None listed