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
Among 18 studies in Diabetes Mellitus by University Health Network, Toronto — 1 open to participants now, 3 under way, none of them phase 3. Diabetes Mellitus · University Health Network, Toronto.
Among the 18 studies in Diabetes Mellitus by University Health Network, Toronto, this one is the 7th largest by planned enrollment of the 14 interventional ones, is one of 2 that started in 2010, is one of 2 in phase 2, and was the 6th registered.
8,290 studies on the registry are indexed under Diabetes Mellitus; 1,077 are open to participants now.
This study's planned enrollment of 48 is below the median of 80 across 6,023 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →1 of the 18 studies in Diabetes Mellitus by University Health Network, Toronto is open now, in 1 country. Each count lists the studies.
Of the 651 Diabetes Mellitus studies recruiting now, 357 (55%) set no upper age limit and 198 (30%) stop at 75 or younger; 87 take children under 18; 183 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →18 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 2 started in 2010.
Median enrollment 39 across the 14 interventional studies, 155 across the 4 observational. Of the 10 that completed or were terminated, 1 (10%) have results posted.
University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
2 of the studies in Diabetes Mellitus by University Health Network, Toronto that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05195944University Health Network, TorontoSemaglutide vs Sitagliptin | 2026-12 |
| NCT05543720University Health Network, TorontoEvaluation of Nurse-led Integrated Care of Complex Patients Facilitated By Telemonitoring: The SMaRT Study | 2026-12 |
Among the 18 studies in Diabetes Mellitus by University Health Network, Toronto, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diabetics undergoing routine cataract surgery
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
Central Retinal Thickness
Time frame: within 3 months after cataract surgery
Best corrected visual acuity and incidence of laser treatments
Time frame: within 3 months after cataract surgery
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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Studies of the drug tested here: Dexamethasone phosphate
University Health Network, Toronto →