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CompletedNCT01030601IDDMECSUpdated Jan 11, 2011

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

A Phase 2 interventional study of Dexamethasone sodium phosphate in Diabetes, Macular Edema and Pseudophakia, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-01-11.

Sponsored by University Health Network, Toronto · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes
  • Macular Edema
  • Pseudophakia

Keywords

  • Diabetic
  • Macular Edema
  • Pseudophakic
  • Dexamethasone
  • Intravitreal
  • Cataract surgery
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
48 participants (estimated)

Study arms

  • 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

Interventions

  • DrugDexamethasone sodium phosphate

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

05

What researchers measure

Primary outcomes

  1. Central Retinal Thickness

    Time frame: within 3 months after cataract surgery

Secondary outcomes

  1. Best corrected visual acuity and incidence of laser treatments

    Time frame: within 3 months after cataract surgery

06

Study locations

1 site
  • Toronto Western Hospital
    Toronto, Ontario M5T 2S8, Canada
07

Registry details

Key details

Study ID
NCT01030601
Lead sponsor
University Health Network, Toronto
First posted
Dec 11, 2009
Start date
Jan 2010
Primary completion
Jan 2011
Completion
Jan 2011
Last update
Jan 11, 2011

Study contacts

Michael H Brent, MD, FRCSC
principal investigator · University Health Network, Toronto
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2011. You cannot join it, but the record below documents what was studied.

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