Changes to the Retina Following Anti-VEGF Treatments for Diabetic Macular Edema

Diabetic Macular Edema Clinical Trial

Official title:

A Clinico-Pathological Study of the Structural and Functional Changes to the Retina Following Anti-VEGF Treatments for Diabetic Macular Edema

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02979665
• Other study ID #: 105570
• Status: Completed
• Start date: September 2014
• Est. completion date: August 2017

Study information

• Verified date: April 2019
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Ranibizumab Ophthalmic
Ranibizumab (trade name Lucentis among others) is a monoclonal antibody fragment (Fab) created from the same parent mouse antibody as bevacizumab. It is an anti-angiogenic that has been approved to treat the "wet" type of age-related macular degeneration (AMD, also ARMD), a common form of age-related vision loss and diabetic macular edema (DME).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

References & Publications (5)

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. — View 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. — View 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. Review. — View Citation

Simó R, Hernández 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of anti-VEGF drugs on intraocular pressure (mmHg)		2 year
Secondary	Effects of anti-VEGF drugs on macular thickness (um)		2 year

External Links

•   Canadian Diabetes Association. Eye Damage (Diabetic Retinopathy).