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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01748487
First received: December 10, 2012
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Diabetic Macular Edema
Drug: OZURDEX
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Study of the Effect of Intravitreal Dexamethasone Implant (700 Micrograms) on Diabetic Macular Edema After Cataract Surgery

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

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. [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: December 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OZURDEX
24 patients will receive an intravitreal injection of OZURDEX at the end of cataract surgery.
Drug: OZURDEX

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748487

Contacts
Contact: Michael Brent, MD +14163007503 mh.brent@utoronto.ca

Locations
Canada, Ontario
UHN, Toronto Western Hospital Recruiting
Toronto, Ontario, Canada, M5T2S8
Contact: Michael Brent, MD    +14163007503    mh.brent@utoronto.ca   
Sponsors and Collaborators
University Health Network, Toronto
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01748487     History of Changes
Other Study ID Numbers: 143BYP
Study First Received: December 10, 2012
Last Updated: October 18, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Edema
Macular Edema
Cataract
Capsule Opacification
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Lens Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014