A 3-Month Clinical Trial to Assess the Safety and Efficacy of the OZURDEX® Intraocular Implant in Patients With Diabetes Mellitus

NCT01673191 | Completed Phase 2 Results

• 1 other identifier: RCA2012
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

There is a need to find an effective therapy for diabetic patients who develop macular edema after cataract surgery.

Conditions

Macular Edema; Diabetes Mellitus

Outcome Measures

Primary Outcomes (7)

• Mean Change in Best Corrected Visual Acuity

  1 months

• Mean Change in Best Corrected Visual Acuity

  2 months

• Mean Change in Best Corrected Visual Acuity

  3 months

• Mean Change in Central Retinal Thickness

  1 month

• Mean Change in Central Retinal Thickness

  2 months

• Mean Change in Central Retinal Thickness

  3 months

• Mean Change in Intraocular Pressure

  3 months

Study Arms (2)

OZURDEX intraocular implant

EXPERIMENTAL

OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg

Drug: Dexamethasone intravitreal implant

Steroid plus NSAID eye drop combination therapy

ACTIVE COMPARATOR

NSAID eye drop: Acular LS Steriod eye drop: Pred Forte

Drug: Steroid plus NSAID eye drop combination therapy

Interventions

Dexamethasone intravitreal implant DRUG

Also known as: OZURDEX

OZURDEX intraocular implant

Steroid plus NSAID eye drop combination therapy DRUG

Also known as: Acular LS and Pred Forte

Steroid plus NSAID eye drop combination therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has diagnosis of Diabetes Mellitus, Type I or II.
• Patient has experienced the development of macular edema following cataract surgery in at least one eye.
• Patient has had cataract surgery within 90 days prior to the screening visit.

You may not qualify if:

• Patient has other significant ocular disease in study eye, including glaucoma.
• Patient has any active infection in the study eye.
• Patient has uncontrolled systemic illness (i.e., uncontrolled blood pressure, uncontrolled diabetes mellitus).
• Patient has experienced a significant increase in intraocular pressure following a prior treatment with topical or intravitreal steroidal medication.
• Patient has received the OZURDEX® implant before in the study eye.

Sponsors & Collaborators

• Retinal Consultants of Arizona: lead
• Allergan: collaborator

Study Sites (1)

Retinal Consultants of Arizona

Phoenix, Arizona, 85014, United States

Location

MeSH Terms

Conditions

Macular Edema; Diabetes Mellitus

Interventions

Dexamethasone; Calcium Dobesilate; Steroids; Ketorolac; prednisolone acetate

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Limitations of our study include a small sample size and short-term follow up. Additional studies are needed to determine whether combination therapy with other treatments would be beneficial to patients.

Results Point of Contact

• Title: Dr. Pravin Dugel
• Organization: Retinal Consultants of Arizona

PDugel@gmail.com

602-222-2221

Study Officials

• Pravin U Dugel, MD

  Retinal Consultants of Arizona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 27, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 5, 2017
• Results First Posted: April 5, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)