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The Effect of Intravitreal Ozurdex on DME After Cataract Surgery

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
dexamethasone intravitreal implant (OZURDEX)
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

  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

Sites / Locations

  • UHN, Toronto Western Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

OZURDEX

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
December 10, 2012
Last Updated
November 30, 2015
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT01748487
Brief Title
The Effect of Intravitreal Ozurdex on DME After Cataract Surgery
Official Title
A Pilot Study of the Effect of Intravitreal Dexamethasone Implant (700 Micrograms) on Diabetic Macular Edema After Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
OZURDEX
Arm Type
Experimental
Arm Description
24 patients will receive an intravitreal injection of OZURDEX at the end of cataract surgery.
Intervention Type
Drug
Intervention Name(s)
dexamethasone intravitreal implant (OZURDEX)
Other Intervention Name(s)
OZURDEX
Intervention Description
intravitreal implant
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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. Diabetics included must have at least level 20 (microaneurysms only) of diabetic retinopathy, defined by the Early Treatment Diabetic Retinopathy Study (ETDRS). Patients must be healthy enough to undergo cataract surgery as decided by their physicians. Patients must be 18 years older and must be able to provide informed consent. Exclusion criteria 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. Patients with advanced glaucoma. Patients with known hypersensitivity to any components of this product or to other corticosteroids. Patients with ACIOL (Anterior Chamber Intraocular Lens) and rupture of the posterior lens capsule Patients who have aphakic eyes with rupture of the posterior lens capsule. 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. Patients with clinical significant macular edema (CSME) measured with OCT prior to surgery will be excluded. Panretinal photocoagulation within the prior 3 months or anticipated need for panretinal photocoagulation within the next 6 months. Patients with retinal diseases, other than diabetes, that can affect ME will be excluded from the study. 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. Eyes with cataract precluding proper optical coherence tomography (OCT) measurement pre-operatively will also be excluded. 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. Patients who are pregnant, breast feeding, or are unable to attend the schedules follow-up appointments will also be excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H Brent, MD
Organizational Affiliation
UHN_Toronto Western Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
UHN, Toronto Western Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T2S8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28196056
Citation
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.
Results Reference
derived

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The Effect of Intravitreal Ozurdex on DME After Cataract Surgery

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