Intravitreal Aflibercept for the Treatment of Treatment Resistant Diabetic Macular Oedema

Phase 4

Recruiting

• Conditions: Diabetic Macular Oedema; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12614001307695
• Lead Sponsor: Andrew Chang

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

*Ability to provide informed consent and complete study assessments
*Age 18 years or older
*Macular oedema involving in central macula secondary to type 1 or type 2 diabetic mellitus in study eye.
*Best corrected baseline visual acuity between 85-34 letters on early treatment in diabetic retinopathy study (ETDRS) chart (Snellen equivalent 6/6 to 6/60) on study eye
*Presence of central diabetic macular odema (DMO) >300 microns on spectral domain optical coherence tomography (SD-OCT) after at least 4 anti-VEGF (vascular endothelial growth factor) treatments within minimum of 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 within 3 months of baseline
*Current vitreous haemorrhage or inflammation in the study eye
*Uncontrolled glaucoma in the study eye. Intraocular pressure (IOP) greater than 30mmHg on maximal medical therapy.
*Active proliferative diabetic retinopathy (PDR) in the study eye.
*Ischemic maculopathy on fluorescein angiography defined as a total area of capillary loss greater than 2 disc areas (> 5mm2) within the ETDRS macular grid or a foveal avascular zone greatest linear diameter of > 1000 microns
*Loss of vision due to other causes (e.g. age related macular degeneration, myopic macular degeneration, retinal vein occlusion)
*Macular oedema due to other causes including vitreous traction
*An ocular condition that would prevent visual acuity improvement despite resolution of oedema (such as foveal atrophy)
*Uncontrolled diabetes mellitus, as defined by HbA1c > 12%
*Severe media opacity
*History of stroke, acute myocardial infarction and transient ischemic attack within 3 months of study enrollment
*Allergy to fluorescein dye.
*Uncontrolled high blood pressure (blood pressure > 180/110 mmHg)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
o increase in macular thickness on Spectral Domain-Optical Coherence Tomography (SD-OCT) at Week 24[Baseline and week 24]

Secondary Outcome Measures

Name	Time	Method
Best corrected (early treatment in diabetic retinopathy study) ETDRS visual acuity[Monthly over a 12 month period];Central foveal thickness (Retinal Pigment Epithelium to Innre Limiting Membrane) measured by SD-OCT[Monthly over a 12 month period];Leakage on fluorescein angiography[Baseline, week 24 and week 48];Peripheral capillary closure measured by standard 7-field color fundus photography, wild-field tomography (HRT3 and Optos)[Baseline, week 12, week 24, week 36 and week 48];Retinal function assessed with Macular Integrity Assessment (MAIA)[Baseline, week 24 and week 48];Health Related Quality of Life by NEI VFQ-25, EQ-5DY and IVI questionnaires[Baseline, week 24 and week 48 for NEI VFQ-25 and IVI.<br>Monthly for EQ-5DY]