Predictors of Treatment Response to Aflibercept and Aqueous Cytokine Levels in Patients With Persistent Diabetic Macular Edema Following Treatment With Ranibizumab: An Interventional Prospective Study
Launched by UNITY HEALTH TORONTO · Jan 7, 2016
Trial Information
Current as of June 28, 2025
Unknown status
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- • Inclusion Criteria
- • Male or female aged 18 years or above
- • Presence of Non Proliferative Diabetic Retinopathy (NPDR)
- • Prior treatment with ≥ 6 intravitreal ranibizumab injections but no treatment in the last 4 weeks and less than 10% improvement in Central Macular Thickness on OCT scan and less than 1 line improvement in vision from baseline and less than 10% reduction in macular volume with Snellan Acuity 20/40 to 20/400
- • Patients with DME with central macular thickness of 310μm or more on SD-OCT (cirrus)
- • Subjects with Type I or II diabetes mellitis
- • Willing and able to provide informed consent for participation in the study
- • Exclusion Criteria
- • Proliferative diabetic retinopathy in the study eye or PRP within the last 12 months or anticipated PRP in the next 6 months
- • Uncontrolled glaucoma
- • History of intraocular surgery within 3 months in the study eye
- • History of vitrectomy surgery
- • Laser treatment within 3 months of study eye
- • Vitreomacular traction, epiretinal membrane or any other maculopathy in the study eye
- • Prior intravitreal injection within the past 6 months
- • Known allergy to the study drug or fluorescein
- • History of stroke or AMI within 6 months of enrolment
- • Patients receiving dialysis for renal failure
- • Patients currently on systemic immunosuppression
- • Patients on two or more class of medication for glaucoma in study eye
- • Patients with tuberculosis
- • Patients who are pregnant.
- • Unwilling or unable to follow or comply with all study related procedures
About Unity Health Toronto
Unity Health Toronto is a leading healthcare organization dedicated to providing exceptional patient care, advancing medical research, and fostering education in the field of health sciences. Comprising St. Michael's Hospital, St. Joseph's Health Centre, and Providence Healthcare, Unity Health integrates a diverse range of clinical services and innovative research initiatives. The organization is committed to improving health outcomes through collaborative partnerships and community engagement, while upholding the highest standards of ethics and integrity in its clinical trials and research endeavors. By focusing on patient-centered approaches, Unity Health Toronto aims to drive advancements in healthcare and contribute to the well-being of the communities it serves.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
Rajeev Muni, MD
Principal Investigator
St. Michael's Hospital Eye Clinic, Toronto, Ontario, Canada, M5C2T2
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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