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Completed

NCT Number: NCT01445626

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

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).

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Key information

Conditions

Macular Edema Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Münster, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dexamethasone intravitreal implant 0.7 mg

Drug

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

Other names: OZURDEX®

Primary outcomes

  1. Time to OZURDEX® Re-injection

    Time frame: Up to 12 months

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

Secondary outcomes

  1. 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

    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.

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

    Time frame: Baseline, Up to 12 months

    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.

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

    Time frame: Baseline, Up to 12 months

    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.

  4. 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

    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.

  5. Time to Improvement of 2 Lines or More in BCVA

    Time frame: Baseline, Up to 12 months

    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).

  6. Time to Improvement of 3 Lines or More in BCVA

    Time frame: Baseline, Up to 12 months

    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).

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Oct 4, 2011
Registry last updated
Feb 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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