Treating neovascular age-related macular degeneration with aflibercept

Not Applicable

Completed

• Conditions: eovascular age-related macular degeneration; Eye Diseases

• Registration Number: ISRCTN58955026
• Lead Sponsor: York Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-02
• Study Completion: 2021-02-26
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the feasibility aspects of the study under these headings i.e. process, resources, management and scientific content.

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration.