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CompletedNCT01748487Updated Dec 2, 2015

The Effect of Intravitreal Ozurdex on DME After Cataract Surgery

A Phase 3 interventional study of dexamethasone intravitreal implant (OZURDEX) in Diabetic Macular Edema, 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 2015-12-02.

Sponsored by University Health Network, Toronto · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
24
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to assess the efficacy and safety of OZURDEX (dexamethasone intravitreal implant) 0.7 mg administered immediately after phacoemulsification and intraocular lens implantation in type 1 or 2 diabetic patients to prevent the occurrence of post-surgical macular edema (ME).

Treatment group: 24 patients will receive an intravitreal injection of OZURDEX at the end of cataract surgery Patients will be seen at 1 week pre-operatively (baseline visit), and on the same day post-surgery (visit 1), at 1 week (visit 2), 1 month (visit 3) and 3 months (visit 4).

BCVA, IOP and SD-OCT will be performed at each visit.

02

Conditions studied

  • Diabetic Macular Edema
03

In context

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,432 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

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

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.

Inclusion criteria

  1. Type 1 or 2 diabetic patients for cataract surgery with > grade 3 cataract type using the Lens Opacities Classification System III. Patients with onset of diabetes before the age of 30 years and minimal or absent endogenous insulin production were classified as having type 1 diabetes. The remaining patients were classified as having type 2 diabetes.
  2. Diabetics included must have at least level 20 (microaneurysms only) of diabetic retinopathy, defined by the Early Treatment Diabetic Retinopathy Study (ETDRS).
  3. Patients must be healthy enough to undergo cataract surgery as decided by their physicians.
  4. Patients must be 18 years older and must be able to provide informed consent.

Exclusion criteria

Exclusion criteria

  1. Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases.
  2. Patients with advanced glaucoma.
  3. Patients with known hypersensitivity to any components of this product or to other corticosteroids.
  4. Patients with ACIOL (Anterior Chamber Intraocular Lens) and rupture of the posterior lens capsule
  5. Patients who have aphakic eyes with rupture of the posterior lens capsule.
  6. Diabetic patients without any retinopathy and those with active uncontrolled proliferative disease will be excluded. We are excluding normal retinas of diabetics since we do not feel they are at particular risk for ME when compared to those who have some form of the disease. A grading of proliferative diabetic retinopathy is based on the criteria made by the ETDRS study, which includes presence of either 1/3 optic disc neovascularization or Ã≠â√∂ optic disc area of neovascularization anywhere elsewhere in the retina.
  7. Patients with clinical significant macular edema (CSME) measured with OCT prior to surgery will be excluded.
  8. Panretinal photocoagulation within the prior 3 months or anticipated need for panretinal photocoagulation within the next 6 months.
  9. Patients with retinal diseases, other than diabetes, that can affect ME will be excluded from the study.
  10. Eyes with uveitis, a history of any other intraocular surgery or a history of uncontrolled glaucoma (baseline IOP higher than 21 mmHg or those using more than one type of glaucoma medication) or steroid responders will not be enrolled in the study.
  11. Eyes with cataract precluding proper optical coherence tomography (OCT) measurement pre-operatively will also be excluded.
  12. Patients who will experience longer than usual operating time, complicated surgery, rupture of the posterior capsule, and iris or corneal burns will be managed accordingly but will be excluded from the study.
  13. Patients who are pregnant, breast feeding, or are unable to attend the schedules follow-up appointments will also be excluded
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    OZURDEX

    24 patients will receive an intravitreal injection of OZURDEX at the end of cataract surgery.

    Drug: dexamethasone intravitreal implant (OZURDEX)

Interventions

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What researchers measure

Primary outcomes

  1. The primary outcome measure will be the change from baseline for the central retinal thickness (CRT) measured by OCT at 3 months after surgery.

    Time frame: 3 months

07

Study locations

1 site
  • UHN, Toronto Western Hospital
    Toronto, Ontario M5T2S8, Canada
08

References and documents

Publications

  • Calvo P, Ferreras A, Al Adel F, Dangboon W, Brent MH. EFFECT OF AN INTRAVITREAL DEXAMETHASONE IMPLANT ON DIABETIC MACULAR EDEMA AFTER CATARACT SURGERY. Retina. 2018 Mar;38(3):490-496. doi: 10.1097/IAE.0000000000001552. PubMed 28196056 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 2, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01748487
Responsible party
Sponsor
First posted
Dec 12, 2012
Start date
Dec 2012
Primary completion
Sep 2015
Completion
Sep 2015
Last update
Dec 2, 2015

Study contacts

Michael H Brent, MD
principal investigator · UHN_Toronto Western Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Dexamethasone Intravitreal Implant

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