NCT02979665

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

May 2, 2019

Status Verified

April 1, 2019

Enrollment Period

2.9 years

First QC Date

November 25, 2016

Last Update Submit

April 30, 2019

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Effects of anti-VEGF drugs on intraocular pressure (mmHg)

    2 year

Secondary Outcomes (1)

  • Effects of anti-VEGF drugs on macular thickness (um)

    2 year

Study Arms (2)

Ranibizumab Ophthalmic

DME consults requiring anti-VEGF treatment

Drug: Ranibizumab Ophthalmic

Control

DME consults not requiring anti-VEGF

Interventions

Ranibizumab OphthalmicDRUG

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).

Also known as: Lucentis
Ranibizumab Ophthalmic

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 18404258BACKGROUND

  • 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.

    PMID: 24525867BACKGROUND

  • 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.

    PMID: 23179897BACKGROUND

  • 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.

    PMID: 22434210BACKGROUND

  • 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.

    PMID: 17980746BACKGROUND

Related Links

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Cindy Hutnik, MD, PhD

    St. Joseph's Health Care London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2016

First Posted

December 1, 2016

Study Start

September 1, 2014

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

May 2, 2019

Record last verified: 2019-04