Phase 2 N=37 Randomized Treatment

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

Macular Edema · Diabetes Mellitus

Bottom Line

View on ClinicalTrials.gov: NCT01673191 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2017

Primary outcome: Primary: Mean Change in Best Corrected Visual Acuity — 0.3; 0.33 logMAR units

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Dexamethasone intravitreal implant (Drug); Steroid plus NSAID eye drop combination therapy (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Retinal Consultants of Arizona
Primary completion: Dec 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Change in Best Corrected Visual Acuity	0.34; 0.21	—
PRIMARY Mean Change in Best Corrected Visual Acuity	0.34; 0.21	—
PRIMARY Mean Change in Best Corrected Visual Acuity	0.34; 0.21	—
PRIMARY Mean Change in Central Retinal Thickness	318.7; 341.1	—
PRIMARY Mean Change in Central Retinal Thickness	318.7; 341.1	—
PRIMARY Mean Change in Central Retinal Thickness	318.7; 341.1	—
PRIMARY Mean Change in Intraocular Pressure	14.9; 14.1	—

Summary

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

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01673191). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.