A Retrospective Data Collection Study in Patients Receiving Dexamethasone Intravitreal Implant (Ozurdex®) for Macular Oedema Due to Retinal Vein Occlusion (RVO)

NCT01445626 | Completed Results

• 1 other identifier: MAF/AGN/OPH/RET/010
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

This study will use retrospective data to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular oedema due to Retinal Vein Occlusion (RVO).

Conditions

Macular Edema

Outcome Measures

Primary Outcomes (1)

• Time to OZURDEX® Re-injection

  Time to OZURDEX® re-injection is the time in days between the first and second OZURDEX® injections.

  Up to 12 months

Secondary Outcomes (6)

• Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection

  Baseline, 7 to 12 weeks following the last injection

• Percentage of Patients With an Increase of 2 Lines or More in BCVA

  Baseline, Up to 12 months

• Percentage of Patients With an Increase of 3 Lines or More in BCVA

  Baseline, Up to 12 months

• Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last Injection

  Baseline, 7 to 12 weeks following the last injection

• Time to Improvement of 2 Lines or More in BCVA

  Baseline, Up to 12 months

Study Arms (1)

All participants

Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.

Drug: dexamethasone intravitreal implant 0.7 mg

Interventions

dexamethasone intravitreal implant 0.7 mg DRUG

Dexamethasone intravitreal implant 0.7 mg was dosed previously according to general clinical practice.

Also known as: OZURDEX®

All participants

Eligibility Criteria

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

Study Population

Patients who received at least 2 injections of OZURDEX® to treat macular oedema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) in at least 1 eye.

You may qualify if:

• Macular oedema in the study eye due to BRVO or CRVO
• Received at least 2 OZURDEX® injections in the study eye

You may not qualify if:

• Received OZURDEX® injections as part of or during any clinical study

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Münster, Germany

Location

MeSH Terms

Conditions

Macular Edema

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; 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

Results Point of Contact

• Title: Vice President Medical Affairs,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 4, 2011
• Study Start: October 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 18, 2013
• Results First Posted: February 18, 2013

Record last verified: 2013-01

Locations

DE (1)