Intravitreal Aflibercept for the Treatment of Treatment Resistant Macular Oedema secondary to Retinal Vein Occlusions

A prospective, open-labelled clinical trial to evaluate the efficacy of intravitreal aflibercept for the treatment of treatment resistant macular oedema secondary to retinal vein occlusion

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12617001487303

Enrollment

Registered

2017-10-20

Start date

2018-01-15

Completion date

2018-01-31

Last updated

2018-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is an open label study in patients who have been previously treated with intravitreal anti-VEGF drug for macular oedema secondary to retinal vein occlusion despite regular injections. The study will describe the effectiveness, safety of intravitreal aflibercept and changes in health related quality of life (HRQoL) among these patients.

Interventions

All subjects will initially receive 3 monthly doses of 2.0mg of intravitreal aflibercept injections and then have 2.0mg of intravitreal aflibercept at two monthly intervals for the subsequent 9 months.

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

Inclusion criteria

• Ability to provide informed consent and complete study assessments • Age 18 years or older • Macular oedema involving central macula secondary to ischemic or non-ischemic BRVO in study eye • Best corrected baseline visual acuity between 20-73 letters on ETDRS chart (Snellen equivalent 6/12 to 6/120) in the study eye. • Presence of central oedema (intra-retinal or sub-retinal fluid) on SD-OCT after at least 4 anti-VEGF treatments within 6 months. • Documentation of the presence of macular oedema at least 30 days since last treatment.

Exclusion criteria

• Pregnancy or lactation. • Premenopausal women not using contraception. • Prior anti-VEGF injection in the study eye within 30 days of baseline. • Prior treatment with triamcinolone in the study eye within 3 months of baseline. • Intraocular surgery in the study eye within 2 months of baseline. • Macular laser within 2 months or previous laser scar would prevent the improvement of macular function. • Prior vitrectomy in the study eye. • Current vitreous haemorrhage or inflammation in the study eye • Uncontrolled glaucoma in the study eye defined as intraocular pressure greater than 30mmHg on maximal medical therapy • grid or a foveal avascular zone greatest linear diameter of > 1000 microns • Loss of vision or macular oedema due to other causes (e.g. age related macular degeneration, myopic macular degeneration, vitreous traction) • An ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy). • Severe media opacity impeding the view of the fundus. • History of stroke, acute myocardial infarction and transient ischemic attack within 3 months of study enrolment. • Allergy to fluorescein dye. • Uncontrolled diabetes mellitus, as defined by haemoglobin A1C (HbA1c) > 12%. • Uncontrolled high blood pressure (blood pressure > 180/110 mmHg)

Outcome results