Chart Review: Drug Utilization Study in Participants Who Received Ozurdex™ (Dexamethasone Intravitreal Implant) 0.7 mg Injections for Visual Impairment Due to Diabetic Macular Edema (DME)

Diabetic Macular Edema Clinical Trial

Official title:

Drug Utilization Study in Patients Receiving Ozurdex™ (Dexamethasone Intravitreal Implant) 0.7 mg Injections for Visual Impairment Due to Diabetic Macular Edema (DME)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03889444
• Other study ID #: CMO-MA-EYE-0564
• Status: Completed
• Start date: January 15, 2019
• Est. completion date: June 7, 2019

Study information

• Verified date: May 2020
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

A retrospective, non-interventional, observational, multi-center, drug utilization study to be conducted in adult participants with visual impairment due to DME treated with Ozurdex implants in Germany and Switzerland from 1 January 2015 to 1 September 2017.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: June 7, 2019
• Est. primary completion date: June 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participant received at least two Ozurdex® implants in the study eye to treat visual impairment due to DME

• First Ozurdex® implant injection occurred after 1 January 2015

• Participant was followed-up at the site for at least 12 months after the first Ozurdex® implant in the study eye

Exclusion Criteria:

• Participant received Ozurdex® implants as part or during a clinical study

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema
• Vision Disorders
• Vision, Low

Intervention

Drug:
• Dexamethasone intravitreal implant
Dexamethasone intravitreal implant 0.7 mg injection, as per routine clinical practice.

Locations

Country	Name	City	State
United States	Clinical Trials Registry Team	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Number of OZURDEX® Implant Reinjections in the Study Eye	Study eye was defined as the eye that received the most OZURDEX® injections.	Up to 44 months
Primary	Time to OZURDEX® Reinjection	The time to reinjection is defined as the time in months from the date of one OZURDEX® injection to the subsequent OZURDEX® injection.	Up to 44 months
Secondary	Change in Best Corrected Visual Acuity (BCVA) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection	BCVA is measured in the study eye (defined as the eye that received the most OZURDEX® injections) following each injection of OZURDEX® using a special eye chart and is reported as number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision. The higher the number of letters read correctly, the better the vision. A positive number indicates improvement. Change data are reported for each injection relative to the assessment immediately prior to the injection to 7 to 12 weeks following that injection.	Last assessment prior to each OZURDEX® injection, 7 to 12 weeks following each injection
Secondary	Change From Baseline in BCVA From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection	BCVA is measured in the study eye (defined as the eye that received the most OZURDEX® injections) following each injection of OZURDEX® using a special eye chart and is reported as number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision. The higher the number of letters read correctly, the better the vision. A positive change from baseline indicates improvement. Change data are reported for each injection relative to the assessment prior the first injection to 7 to 12 weeks following each injection.	Baseline (Last assessment prior to the first OZURDEX® injection), 7 to 12 weeks following each injection
Secondary	Change in Central Retinal Thickness (CRT) by Optical Coherence Tomography (OCT) From the Last Assessment Prior to Each OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection	OCT is measured in the study eye (defined as the eye that received the most OZURDEX® injections) prior to and following each injection of OZURDEX®. OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement. Change data are reported for each injection relative to the assessment immediately prior to the injection to 7 to 12 weeks following that injection.	Last assessment prior to each OZURDEX® injection, 7 to 12 weeks following each injection
Secondary	Change From Baseline in CRT by OCT From the Last Assessment Prior to the First OZURDEX® Implant Injection to 7-12 Weeks Following Each OZURDEX® Implant Injection	OCT is measured at Baseline and following each injection of OZURDEX® in the study eye (defined as the eye that received the most OZURDEX® injections . OCT is a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina to assess retinal thickness. A negative change indicates an improvement. Change data are reported for each injection relative to the assessment prior the first injection to 7 to 12 weeks following each injection.	Baseline (Last assessment prior to the first OZURDEX® injection), 7 to 12 weeks following each injection
Secondary	Percentage of Participants Who Experienced At Least One Adverse Events of Special Interest (AESIs)	An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a drug whether or not it is considered related to the drug. The adverse events of special interest include: Glaucoma, defined as damage to the optic nerve with progressive vision loss, Intraocular hypertension, defined as intra-ocular pressure (IOP) without meeting the criteria for glaucoma, Hypotony, defined as low IOP =5 mmHg, Cataract or lens opacities, Ocular bleeding or hemorrhage, Retinal detachment, tear or hole, Vitreous detachment, Infection vs. Non-infection related Ocular inflammation, Significant vitreous loss, Mechanical failure of device and implant misplacement, Implant dislocation.	Up to 44 months

External Links

•   Additional information on study locations near you may be found at AllerganClinicalTrials.com. For any study not on AllerganClinicalTrials.com, please contact IR-CTRegistration@Allergan.com for assistance.