The Effect of Intravitreal Ozurdex on DME After Cataract Surgery

Diabetic Macular Edema Clinical Trial

Official title:

A Pilot Study of the Effect of Intravitreal Dexamethasone Implant (700 Micrograms) on Diabetic Macular Edema After Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748487
• Other study ID #: 143BYP
• Status: Completed
• Phase: Phase 3
• First received: December 10, 2012
• Last updated: November 30, 2015
• Start date: December 2012
• Est. completion date: September 2015

Study information

• Verified date: November 2015
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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?âv? 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Capsule Opacification
• Diabetic Macular Edema
• Macular Edema

Intervention

Drug:
• dexamethasone intravitreal implant (OZURDEX)
intravitreal implant

Locations

Country	Name	City	State
Canada	UHN, 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	The primary outcome measure will be the change from baseline for the central retinal thickness (CRT) measured by OCT at 3 months after surgery.		3 months	No