None listed
Conditions
Brief summary
In this prospective case series participants with cystoid macula oedema secondary to Central Retinal Vein Occlusion (CRVO) who are treatment naive will receive treatment with Eylea using an ‘inject and extend’ treatment protocol. In this study we aim to assess whether a ‘treat and extend’ regimen is a useful option in the treatment of CME associated with CRVO. We hypothesise that visual acuity outcomes will be non-inferior to that achieved in the pivotal trials and that this will be achieved with fewer visits to the clinic. The study will run for approximately 36 months. The recruitment period will last approximately 12 months. Participant involvement will last approximately 24 months.
Interventions
All patients entered into the study will receive intravitreal injections of Aflibercept (Eylea) 2 mg/ 0.05mls. All patient's will be required to have an injection every month for a minimum of 3 months. After the mandatory 3 injections (week 8) BCVA, fundal examination and OCT assessment of the patient is used to determine the presence of residual CME.
- If there is continued BCVA improvement of greater than or equal to 5 letters from the previous visit further injections will be given at a 4 we
All patients entered into the study will receive intravitreal injections of Aflibercept (Eylea) 2 mg/ 0.05mls. All patient's will be required to have an injection every month for a minimum of 3 months. After the mandatory 3 injections (week 8) BCVA, fundal examination and OCT assessment of the patient is used to determine the presence of residual CME. - If there is continued BCVA improvement of greater than or equal to 5 letters from the previous visit further injections will be given at a 4 weekly until there is no further improvement. Once BCVA is stable (within 5 letters of best recorded acuity), the OCT is free of either SRF or IRF and CMT is within 50 microns of previous best (minimum) recorded, an injection is given and the interval between the next visit is extended by two weeks up to a maximum of 12 weeks. - During the period of extension, if there is a reduction in BCVA greater than or equal to 5 letters, evidence of recurrent SRF/ IRF or an increase of greater than or equal to 50 microns (from previous best recorded CMT), an aflibercept injection will be given and the follow up interval will be reduced by 2 weeks. Following this protocol the time between injections will be extended by 2 weeks at each visit if the patient’s condition is stable, Using this treatment regimen, each patient receives at least seven injections in the first year. In the second year treatment may continued as per the criteria in year one, in addition treatment be suspended based on BCVA, OCT and fundus examination. Rescue treatment of intravitreal steroid or scatter laser may be performed if required.
Sponsors
Centre for Eye Research Australia
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age greater than or equal to18 years 2. CRVO with cystoid macular as determined by fluorescein angiography and duration of onset less than 12 months 3. Best-corrected visual acuity (BCVA) of 17-70 letters (6/12 –6/120) 4. Central macular thickness of greater than or equal to 300 microns as measured by Heidelberg Optical coherence tomography. 5. Absent relative afferent pupillary defect
Exclusion criteria
Systemic 1. Uncontrolled blood pressure (greater than or equal to180 mmHg, systolic and 110 mmHg, diastolic) 2. Chronic renal failure 3. Major surgery within one month of study 4. Previous systemic anti-VEGF treatment 5. Women of childbearing potential not using adequate contraception and women who are breast feeding 6. Intercurrent severe disease such as septicaemia Ocular 1. Glaucoma which is uncontrolled with intraocular pressure-lowering medications 2. Past history of severe steroid response with IOP greater than or equal to 35 mmHg following steroid treatment 3. Loss of vision due to other causes (e.g. age-related macular degeneration, myopic macular degeneration) 4. VA of <6/60 in the fellow eye 5. Argon laser photocoagulation within 3 months of study entry 6. Previous intraocular surgery (within 6 months) 7. Stroke or myocardial infarction less than 3 months prior to screening. 8. Any active periocular or ocular infection or inflammation at screening or baseline. 9. Subjects, who in the opinion of the Investigator, may not benefit from the Investigational Product due to pre-existing or current macular condition (eg, vitreomacular traction, epiretinal membrane, scar, foveal atrophy)
Outcome results
None listed