Analysis of the Effect of Intravitreal Dexamethasone Injection on Diabetic Macular Edema After Cataract Surgery (IDDMECS)

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01030601
First received: December 9, 2009
Last updated: January 10, 2011
Last verified: January 2011
  Purpose

Macular Edema (Swelling of a particular site of the retina) can become a significant problem for Diabetics undergoing Cataract surgery. And a significant number of people who undergo Cataract surgery each year are diabetics. And when you multiply these two factors together you are left with a significant number of people who do not gain as much vision as their peers. Diabetics who develop Macular Edema actually can loose some vision after surgery and when you follow them up, they don't gain as much vision. This Study aims to prevent such an event from happening and therefore allow Diabetics to gain as much vision as they can from cataract surgery. This study will use Dexamethasone injected intravitreally (into the gel of the eye) at the end of cataract extraction to control Macular edema brought about by surgery. The main outcome is the central retina thickness and retinal volume as measured by Optical Coherence Tomography. Secondary outcomes are BCVA and incidence of Laser Treatment.

Other Drugs, life Bevacizumab and Pegaptanib, have been used for this purpose but they are expensive and have potential systemic side-effects due to anti-VEGF (vascular endothelial growth factor) actions. Dexamethasone has been used in the eye for decades and is short-lived, minimizing possible systemic effects. Moreover, this drug is at least 15x cheaper than the previously mentioned ones and therefore has tremendous benefit for developing countries. We seek an alternative drug that can reduce or prevent Macular edema at a less expensive and safer way.


Condition Intervention Phase
Diabetes
Macular Edema
Pseudophakia
Drug: Dexamethasone sodium phosphate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Analysis of the Effect of Intravitreal Dexamethasone Injection on Diabetic Macular Edema After Cataract Surgery (IDDMECS)

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Central Retinal Thickness [ Time Frame: within 3 months after cataract surgery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Best corrected visual acuity and incidence of laser treatments [ Time Frame: within 3 months after cataract surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: January 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Diabetics undergoing routine cataract surgery
Experimental: Treatment
Diabetics undergoing cataract surgery with injection of 0.5mg in 0.05cc of dexamethasone at the end of surgery
Drug: Dexamethasone sodium phosphate
0.5mg in 0.05cc of Dexamethasone from a 10mg/ml vial

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetic patients for Cataract Surgery with vision of ≤ 20/50 and > grade 3 any cataract type using the Lens Opacities Classification System III. Diabetics included must have at least one microaneurysm in the posterior pole (defined by the Superior and Inferior Arcade).

Exclusion Criteria:

  • Without any diabetic retinopathy and those with active uncontrolled proliferative disease
  • Retinal disease,other than Diabetes, that can affect macular edema
  • Uveitis, a history of any other intraocular surgery or a history of uncontrolled glaucoma
  • Eyes with cataract precluding proper OCT measurement pre-operatively
  • Patients who will experience longer than usual operating time, complicated surgery, rupture of the posterior capsule, and iris or corneal burns
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030601

Locations
Canada, Ontario
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Michael H Brent, MD, FRCSC University Health Network, Toronto
  More Information

No publications provided

Responsible Party: Dr. Michael Brent, MD, FRCSC, Toronto Western Hospital
ClinicalTrials.gov Identifier: NCT01030601     History of Changes
Other Study ID Numbers: IDDMECS
Study First Received: December 9, 2009
Last Updated: January 10, 2011
Health Authority: Canada: Health Canada

Keywords provided by University Health Network, Toronto:
Diabetic
Macular Edema
Pseudophakic
Dexamethasone
Intravitreal
Cataract surgery

Additional relevant MeSH terms:
Edema
Cataract
Macular Edema
Capsule Opacification
Pseudophakia
Signs and Symptoms
Lens Diseases
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014