Clinical trial NCT02979665: Changes to the Retina Following Anti-VEGF Treatments for Diabetic Macular Edema
Official title: A Clinico-Pathological Study of the Structural and Functional Changes to the Retina Following Anti-VEGF Treatments for Diabetic Macular Edema
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Macular Edema
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2016-12-01
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: DR consults referred to the Ivey Eye Institute and requiring anti-VEGF injections in at least one eye due to DME will be recruited into the study.

Brief summary: anti-VEGF therapy is an established method to control leakage and abnormal growth of retinal blood vessels. Questions on the long-term effect on the retina, intraocular pressure and on the overall retinal perfusion from these treatments remain to be answered. The purpose of the study was to evaluate changes in the retina following anti-VEGF treatment over time, using structural and functional diagnostic tests.

Detailed description: Diabetic retinopathy (DR) causes changes in the capillaries that nourish the retina. Two treatments clinically used for DR are laser photocoagulation to reduce the angiogenic drive by knocking off metabolically active retina and anti-VEGF drugs for diabetic macular edema (DME). DME affects approximately 2.5% of the nearly 2.4 million Canadians with diabetes, or approximately 60,000 Canadians, making it a major cause of adult-onset vision loss. DME occurs when blood vessels in the retina of diabetic patients become leaky resulting in unwanted fluid accumulation in the center of vision known as the macula. If not treated, this can lead to blindness. Originally used in the treatment of age-related macular degeneration (AMD), anti-VEGF drugs are increasingly used to control leakage and abnormal growth of retinal blood vessels. Numerous questions have emerged following the usage of anti-VEGF medications in the eye such as their long-term effects of these drugs on intraocular pressure and on the overall retinal perfusion. By recruiting DR patients requiring anti-VEGF treatment for DME, this study will answer whether long-term usage of anti-VEGF will result in structural and functional changes to the retina.

Eligibility criteria: Inclusion Criteria:

* DME patients
* Require anti-VEGF injections in at least one eye

Exclusion Criteria:

* Advanced lens opacity or cataract that could affect diagnostic testing
* Prior retinal treatment (PRP, focal laser or surgery within 6 months of participation)

Primary outcomes:
measure: Effects of anti-VEGF drugs on intraocular pressure (mmHg)
timeFrame: 2 year
Secondary outcomes:
measure: Effects of anti-VEGF drugs on macular thickness (um)
timeFrame: 2 year
Other outcomes:
Locations:
Study officials:
affiliation: St. Joseph's Health Care London
name: Cindy Hutnik, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simo R, Hernandez C. Intravitreous anti-VEGF for diabetic retinopathy: hopes and fears for a new therapeutic strategy. Diabetologia. 2008 Sep;51(9):1574-80. doi: 10.1007/s00125-008-0989-9. Epub 2008 Apr 11.
citation: Osaadon P, Fagan XJ, Lifshitz T, Levy J. A review of anti-VEGF agents for proliferative diabetic retinopathy. Eye (Lond). 2014 May;28(5):510-20. doi: 10.1038/eye.2014.13. Epub 2014 Feb 14.
citation: Singh RS, Kim JE. Ocular hypertension following intravitreal anti-vascular endothelial growth factor agents. Drugs Aging. 2012 Dec;29(12):949-56. doi: 10.1007/s40266-012-0031-2.
citation: Mathalone N, Arodi-Golan A, Sar S, Wolfson Y, Shalem M, Lavi I, Geyer O. Sustained elevation of intraocular pressure after intravitreal injections of bevacizumab in eyes with neovascular age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2012 Oct;250(10):1435-40. doi: 10.1007/s00417-012-1981-0. Epub 2012 Mar 21.
citation: Neubauer AS, Kook D, Haritoglou C, Priglinger SG, Kampik A, Ulbig MW, Ceklic L. Bevacizumab and retinal ischemia. Ophthalmology. 2007 Nov;114(11):2096. doi: 10.1016/j.ophtha.2007.05.057. No abstract available.