Retrospective Study in Patients Receiving Two or More OZURDEX® Injections for Retinal Vein Occlusion (RVO)

NCT01411696 | Completed Results

• 2 other identifiers: GMA-OZU-09-011GMA-320
• Study Type: observational
• Target: 289
• Locations: 1 country
• Sites: 1

Brief Summary

This is a retrospective data collection study to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular edema due to RVO. Following informed consent, there were no patient study visits. All data was collected via chart review.

Conditions

Retinal Vein Occlusion; Macular Edema

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection

  BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worst) to 20 (best). The change in BCVA was calculated using the most improved number of lines read correctly between 4 and 20 weeks following the last injection of OZURDEX® - the number of lines read correctly at baseline. A positive change from baseline indicates improvement.

  Baseline, 4 to 20 weeks after last injection (Up to 6 months)

Secondary Outcomes (3)

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

  Baseline, Up to 6 months

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

  Baseline, Up to 6 months

• Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection

  Baseline, 4 to 20 Weeks after Each injection (up to 6 months)

Study Arms (1)

All Participants

Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.

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 edema due to RVO in at least one eye.

You may qualify if:

• Macular edema
• Received at least 2 OZURDEX® injections

You may not qualify if:

• Received OZURDEX® injections as part of a clinical study

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

San Antonio, Texas, United States

Location

Related Publications (2)

• Dugel PU, Capone A Jr, Singer MA, Dreyer RF, Dodwell DG, Roth DB, Shi R, Walt JG, Scott LC, Hollander DA; SHASTA Study Group. Two or more dexamethasone intravitreal implants in treatment-naive patients with macular edema due to retinal vein occlusion: subgroup analysis of a retrospective chart review study. BMC Ophthalmol. 2015 Sep 4;15:118. doi: 10.1186/s12886-015-0106-z.

  PMID: 26337664 DERIVED

• Singer MA, Capone A Jr, Dugel PU, Dreyer RF, Dodwell DG, Roth DB, Shi R, Walt JG, Scott LC, Hollander DA; SHASTA Study Group. Two or more dexamethasone intravitreal implants as monotherapy or in combination therapy for macular edema in retinal vein occlusion: subgroup analysis of a retrospective chart review study. BMC Ophthalmol. 2015 Apr 1;15:33. doi: 10.1186/s12886-015-0018-y.

  PMID: 25885285 DERIVED

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Macular Degeneration; Retinal Degeneration

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: August 5, 2011
• First Posted: August 8, 2011
• Study Start: July 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: April 16, 2013
• Results First Posted: April 16, 2013

Record last verified: 2013-03

Locations

US (1)