Intravitreal Aflibercept for the treatment of diabetic macular oedema
- Conditions
- Diabetic Macular OedemaEye - Diseases / disorders of the eyeMetabolic and Endocrine - Diabetes
- Registration Number
- ACTRN12618000428268
- Lead Sponsor
- itin Verma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 26
•Written informed consent must be obtained prior to any study measures being performed
•Male or female participants aged 18 years and over, with type 1 or type 2 diabetes mellitus
•Female patients of childbearing potential should be counselled on potential risks and should use effective contraceptive measures during treatment and for up to three months after treatment ceases.
•Diagnosis of diabetic macular oedema (DME) with central macular involvement in study eye diagnosed by fluorescein angiography.
•Decrease in vision in the study eye as a consequence of DME
•Best corrected baseline visual acuity (BCVA) between 24 and 78 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 3 meters.
•Study eye Central retinal thickness (CRT) at least 300µm on OCT ( Heidelberg Spectralis OCT)
•Pregnant or lactating women and women of reproductive age not using effective contraception.
•Systemic disease or a condition (controlled or uncontrolled) that, in the opinion of the investigator, might regress, recur or change and consequently have a potential impact (bias) on the assessment of study outcomes.
•Stroke or myocardial infarction less than 3 months prior to screening for eligibility.
•Uncontrolled blood pressure (defined as a systolic of >160mmHg or diastolic >100mmHg) at screening
•Uncontrolled diabetes, defined by HBA1c>12%
•Patients with known sensitivity to Aflibercept preparations
•Patients taking or planning to take any systemic medications known to be toxic to the lens or retina or optic nerve.
•Any active ocular or peri-ocular infection or inflammation
•Active proliferative diabetic retinopathy in study eye.
•Visually significant cataract
•Any other macular pathology in the study eye that may influence the outcomes of the study (e.g. laser burns or scars, wet Age-related macular degeneration, macular holes.)
•Uncontrolled glaucoma
•Any previous treatment with anti-angiogenic drugs in the study eye within 120 days of commencing the study.
•Any previous treatment with anti-angiogenic drugs in the fellow eye within 90 days of commencing the study.
•More than two previous macular laser photocoagulation treatments in the study eye in the past 6 months.
•Pan-retinal or macular laser photocoagulation in study eye within the 90 days of commencing the study.
•Treatment of study eye with intraocular /peri ocular corticosteroids within 120 days of commencing the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Best Corrected Visual acuity (early diabetic retinopathy study) EDTRS<br><br>[Baseline, at each follow up visit. week 20, 1 year and 2 years [primary time point]];The proportions of participants whose visual acuity has improved by 10 letters or more and 15 letters or more [1 year, 2 years [primary timepoint]]
- Secondary Outcome Measures
Name Time Method Any untoward medical occurrence after the participant signs the informed consent will be recorded as an adverse event. <br>Adverse events include: those associated with the injection procedure such as eye irritation, severe eye pain, reduction or clouding of vision, flashes of light or floaters, bloodshot eyes, Other changes in the participants health such as coughs, colds, chest infections, urinary tract infections, falls, disturbances in blood sugar control, unplanned hospitalisations will be identified through questioning the participant at each visit or between visits or as a result of participant examination or other assessments or medical reports from other health professionals. [Baseline, at each visit, 1 year, 2 years ];Changes in the retinal pigmented epithelium (central foveal thickness and volume) measured by SD-OCT[Baseline, at each follow up visit, week 20, 1 year and 2 years ];Number of injections[1 year, 2 years ]