Lucentis (Ranibizumab) in Diabetic Macular Oedema: a Treatment Evaluation

Launched by MOORFIELDS EYE HOSPITAL NHS FOUNDATION TRUST · Oct 18, 2010

Keywords

ClinConnect Summary

Adult patients with centre-involving diabetic macular oedema will be recruited to this single-centre study. Patients will undergo detailed baseline evaluation which will include:

* vision testing
* optical coherence tomography scanning
* fundus fluorescein angiography
* microperimetry
* colour contrast sensitivity testing
* electrophysiological testing

Patients will be randomised 2:1 to receive either ranibizumab intravitreal injection 4-weekly for 48 weeks or modified ETDRS macular laser therapy 12-weekly for 48 weeks.

Both groups of patients will return at 12, 24 and 48 weeks for repea...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Diagnosis of diabetes mellitus (type 1 or type 2)
• • Retinal thickening due to diabetic macular oedema involving the centre of the macula and OCT central subfield ≥ 300 microns
• • Best corrected visual acuity in the study eye between 55 and 79 ETDRS letters at 1 metre (Snellen equivalent ≥ 6/24 and ≤ 6/9)
• • Media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs
• • Intraocular pressure less than 30 mmHg
• • Ability to return for study visits
• • Visual acuity in fellow eye ≥ 2/60
• • Fellow eye has received no anti-VEGF treatment within the past 3 months and no expectation of such treatment in next 12 months
• • No previous laser within 3 months of randomisation
• • Ability to give informed consent throughout the duration of the study
• Exclusion Criteria:
• • Macular ischaemia
• • Macular oedema from a cause other than diabetic macular oedema
• • Co-existent ocular disease
• • Presence of an ocular condition such that visual acuity would not improve from resolution of macular oedema
• • Presence of an ocular condition that might affect macular oedema or alter visual acuity during the course of the study
• • A substantial cataract that is likely to be decreasing visual acuity by 3 lines or more
• • History of treatment for diabetic macular oedema at any time in the past 3 months
• • History of panretinal scatter photocoagulation (PRP) within 3 months prior to randomisation
• • Anticipated need for PRP in the 6 months following randomisation.
• • Proliferative diabetic retinopathy in the study eye.
• • A condition that, in the opinion of the investigator, would preclude participation in the study.
• • Haemoglobin A1c \> 11.0 %
• • A past medical history of significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant
• • Blood pressure \>170/100 mmHg
• • Myocardial infarction, other cardiac event requiring hospitalisation, stroke, transient ischaemic attack, or treatment for acute congestive heart failure within 6 months prior to randomisation
• • Major surgery within 28 days prior to randomisation or major surgery planned during the next 12 months at baseline
• • Participation in an investigational trial within 30 days of randomisation that involved treatment with any drug that has not received regulatory approval at the time of study entry. Note: subjects cannot receive another investigational drug while participating in the study
• • Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomisation
• • Pregnant or lactating women or women intending to become pregnant within the study period including 3 months after study cessation
• • History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery) within prior 3 months or anticipated within the next 6 months following randomisation.
• • Aphakia
• • Uncontrolled glaucoma
• • External ocular infection, including conjunctivitis, chalazion, or severe blepharitis
• • Known allergy to fluorescein dye or to any component of the study drug
• • Fertile male unwilling to use contraception for the duration of the study