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

Diabetes Clinical Trial

— IDDMECS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01030601
• Other study ID #: IDDMECS
• Status: Completed
• Phase: Phase 2
• First received: December 9, 2009
• Last updated: January 10, 2011
• Start date: January 2010
• Est. completion date: January 2011

Study information

• Verified date: January 2011
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2011
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Capsule Opacification
• Cataract
• Diabetes
• Edema
• Macular Edema
• Pseudophakia

Intervention

Drug:
• Dexamethasone sodium phosphate
0.5mg in 0.05cc of Dexamethasone from a 10mg/ml vial

Locations

Country	Name	City	State
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Retinal Thickness		within 3 months after cataract surgery	No
Secondary	Best corrected visual acuity and incidence of laser treatments		within 3 months after cataract surgery	No