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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01445626
First received: September 30, 2011
Last updated: January 14, 2013
Last verified: January 2013
  Purpose

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).


Condition Intervention
Macular Edema
Drug: dexamethasone intravitreal implant 0.7 mg

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Time to OZURDEX® Re-injection [ Time Frame: Up to 12 months ] [ Designated as safety issue: No ]
    Time to OZURDEX® re-injection is the time in days between the first and second OZURDEX® injections.


Secondary Outcome Measures:
  • Change From Baseline in Best Corrected Visual Acuity (BCVA) 7 to 12 Weeks Following the Last Injection [ Time Frame: Baseline, 7 to 12 weeks following the last injection ] [ Designated as safety issue: No ]
    BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of letters ranging from 0 (worse) to 100 (best). The change in BCVA was calculated using the most improved number of letters read correctly between 7 and 12 weeks following the last injection of OZURDEX® - the number of letters read correctly at baseline. A positive change from baseline indicates improvement.

  • Percentage of Patients With an Increase of 2 Lines or More in BCVA [ Time Frame: Baseline, Up to 12 months ] [ Designated as safety issue: No ]
    BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 2 or more lines read correctly compared to baseline is an improvement.

  • Percentage of Patients With an Increase of 3 Lines or More in BCVA [ Time Frame: Baseline, Up to 12 months ] [ Designated as safety issue: No ]
    BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best). An increase of 3 or more lines read correctly compared to baseline is an improvement.

  • Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 7 to 12 Weeks Following the Last Injection [ Time Frame: Baseline, 7 to 12 weeks following the last injection ] [ Designated as safety issue: No ]
    Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at baseline and 7 to 12 weeks after the last injection. A negative change from baseline indicates improvement.

  • Time to Improvement of 2 Lines or More in BCVA [ Time Frame: Baseline, Up to 12 months ] [ Designated as safety issue: No ]
    Time to improvement of 2 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 2 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best).

  • Time to Improvement of 3 Lines or More in BCVA [ Time Frame: Baseline, Up to 12 months ] [ Designated as safety issue: No ]
    Time to improvement of 3 lines or more in BCVA is defined as the number of days after the first injection of OZURDEX® to achieve an improvement of 3 or more lines read correctly compared to baseline. BCVA was assessed using the Snellen eye chart converted to Early Treatment Diabetic Retinopathy Study number of lines ranging from 0 (worse) to 20 (best).


Enrollment: 87
Study Start Date: October 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All participants
Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
Drug: dexamethasone intravitreal implant 0.7 mg
Dexamethasone intravitreal implant 0.7 mg was dosed previously according to general clinical practice.
Other Name: OZURDEX®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Received OZURDEX® injections as part of or during any clinical study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01445626

Locations
Germany
Muenster, Germany
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01445626     History of Changes
Other Study ID Numbers: MAF/AGN/OPH/RET/010
Study First Received: September 30, 2011
Results First Received: January 14, 2013
Last Updated: January 14, 2013
Health Authority: Germany: Ministry of Health

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Cardiovascular Diseases
Embolism and Thrombosis
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Signs and Symptoms
Thrombosis
Vascular Diseases
Venous Thrombosis
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 29, 2014