Neovascular age-related macular degeneration Eye Diseases
Conditions
Interventions
Participants are randomly allocated to one of two groups. Both groups will receive intravitreal injections of aflibercept 2 mg.
Control group: Participants receive initial 3 doses of
Sponsors
York Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 50 years or above 2. Able to provide written, informed consent to the study 3. Able and willing to attend for hospital visits at the frequency required 4. Visual impairment predominantly due to neovascular age–related macular degeneration (AMD). 5. Active, treatment naive, angiographically active choroidal neovascular membrane in the study eye secondary to neovascular AMD with any part of the lesion or its sequelae (e.g. sub retinal fluid, intra retinal fluid, haemorrhage, pigment epithelial detachment, sub retinal pigment epithelium(RPE) fluid) in a sub foveal location 6. Visual acuity of 7824 ETDRS letters at screening and baseline in the study eye. 7. If both eyes are eligible at baseline, the worst seeing eye will be included in the study although the final decision will rest with the investigator. Any deviation from entering the worst seeing eye into the study will be explained and documented in the patient notes and the CRF. The choice of eye selected for inclusion into the study will be determined and documented before the patient is randomised. A patient who has both eyes that may be eligible may therefore undergo a different treatment regimen in each eye, however they will be treated with aflibercept in both eyes. Hospital visits will be co-ordinated to minimise the number of attendances required and therefore the inconvenience for the patient.
Exclusion criteria
Exclusion criteria: 1. Inability to comply with the study or follow up procedures 2. Pregnant or lactating women 3. Women of child bearing potential unless they are using effective methods of contraception (total abstinence, female or male sterilization, barrier contraception, intrauterine device, oral or injectable hormonal methods of contraception) 4. Previous treatment for choroidal neovascularisation in the study eye 5. Fibrosis consisting of more than 50% of the lesion or involving the centre of the fovea 6. Coexisting pathology within 0.5 disc diameters of the fovea that could prevent an improvement in visual acuity in the opinion of the investigator (e.g. macular hole, dense epi - retinal membrane) 7. Cataract (causing significant visual impairment), aphakia, vitreous haemorrhage, retinal detachment, proliferative retinopathy or CNV due to any cause other than AMD at screening and baseline 8. Known allergy to aflibercept or fluorescein 9. History of cerebrovascular accident, transient ischemic attack or myocardial infarction within 3 months of the screening visit 10. Any type of systemic disease or treatment that may affect or expect to affect the clinical status of the patient to a significant degree 11. Blood pressure of >160mmHg systolic or >100mmHg diastolic at screening or baseline 12. Any active periocular infection or inflammation at screening or baseline 13. Uncontrolled glaucoma (30mmHg) at screening or baseline 14. Neovascularisation of the iris at screening or baseline 15. Treatment with any anti angiogenic drugs to either eye within 3 months of baseline 16. Nd-YAG laser capsulotomy within the last 2 months or expected within 6 months of baseline in the affected eye 17. Use of other investigational drugs within 30 days 18. Use of systemic anti –vascular endothelial growth factor agents within 3 months prior to baseline 19. Use of systemic corticosteroids for at least 30 consecutive days within the 3 months prior to baseline 20. Current or planned medications known to be toxic to the lens, retina or optic nerve e.g. hydroxychloroquine, desferoxamine, tamoxifen or ethambutol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the feasibility aspects of the study under these headings i.e. process, resources, management and scientific content. | — |
Secondary
| Measure | Time frame |
|---|---|
| Not provided at time of registration. | — |
Countries
England, United Kingdom
Contacts
Public ContactTom Szczerbicki
Outcome results
None listed