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

NCT01030601 | Completed Phase 2

• 1 other identifier: IDDMECS
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes; Macular Edema; Pseudophakia

Keywords

Diabetic; Macular Edema; Pseudophakic; Dexamethasone; Intravitreal; Cataract surgery

Outcome Measures

Primary Outcomes (1)

• Central Retinal Thickness

  within 3 months after cataract surgery

Secondary Outcomes (1)

• Best corrected visual acuity and incidence of laser treatments

  within 3 months after cataract surgery

Study Arms (2)

Control

NO INTERVENTION

Diabetics undergoing routine cataract surgery

Treatment

EXPERIMENTAL

Diabetics undergoing cataract surgery with injection of 0.5mg in 0.05cc of dexamethasone at the end of surgery

Drug: Dexamethasone sodium phosphate

Interventions

Dexamethasone sodium phosphate DRUG

0.5mg in 0.05cc of Dexamethasone from a 10mg/ml vial

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus; Macular Edema; Pseudophakia

Interventions

dexamethasone 21-phosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael H Brent, MD, FRCSC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 9, 2009
• First Posted: December 11, 2009
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: January 11, 2011

Record last verified: 2011-01

Locations

CA (1)