Suspended

ORIONOzurdex Versus Ranibizumab Versus Combination for Central Retinal Vein

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What is being tested

Ozurdex

+ Ranibizumab

+ Combination Ozurdex with Ranibizumab PRN

Drug
Who is being recruted

Cardiovascular Diseases+8

+ Eye Diseases

+ Macular Degeneration

Over 18 Years
+25 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: May 2013
See protocol details

Summary

Principal SponsorValley Retina Institute
Study ContactVICTOR H GONZALEZ, MDMore contacts
Last updated: December 14, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2013

Actual date on which the first participant was enrolled.

This is a 52 week, single masked, 1:1:1, randomized, phase IV, multicenter injection controlled clinical study with a 24 week treatment phase followed by a 24 week follow up phase. Subjects will be randomly assigned to Ozurdex every 16 weeks, Ranibizumab monthly, or combination Ozurdex every 16 weeks with Ranibizumab. Patients assigned to IV Ozurdex arm will receive a total of 2 intravitreal Ozurdex injections (in combination with monthly Ranibizumab sham) administered at 16 week intervals beginning on Day 1 and ending at Week 16. Patients assigned to IV Ranibizumab arm will receive injections administered at monthly intervals (in combination with Ozurdex sham beginning on Day 1 and Week 16). Patients assigned to IV Ozurdex with IV Ranibizumab will receive a total of 2 intravitreal Ozurdex injections administered at Week 16 intervals beginning on Day 1 and ending at Week 16 with an initial IV Ranibizumab injection administered on Day 1, then treated with Ranibizumab according to reinjection parameters assessed monthly through Week 20 (in combination with Ranibizumab sham if Ranibizumab reinjection parameters are not met). Treatment at end of study treatment phase Week 24 will be standard of care for all arms at the Investigator's discretion.

NCT01827722
Principal SponsorValley Retina Institute
Study ContactVICTOR H GONZALEZ, MDMore contacts
Last updated: December 14, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

45 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesEye DiseasesMacular DegenerationRetinal DegenerationRetinal DiseasesThrombosisVascular DiseasesEmbolism and ThrombosisVenous ThrombosisMacular EdemaRetinal Vein Occlusion

Criteria

5 inclusion criteria required to participate
Ability to provide signed informed consent form
Adults greater than or equal to 18 years of age with foveal center involved macular edema secondary to CRVO diagnosed within 12 months before the screening visit (CRVO is defined as an eye with retinal hemorrhage or other biomicroscopic evidence of RVO [eg telangiectatic capillary bed] and a dilated [or previously dilated] venous system in at least 3 quadrants of the retina drained by the affected vein
Best corrected visual acuity (ETDRS) letter score of 73 to 24 inclusive (20/40 to 20/320) in the study eye at Screening and at Day 1
Mean central subfield thickness greater than or equal to 310 μm from 2 OCT measurements (Spectralis HRA + OCT) at Screening and Day 1
Show More Criteria
20 exclusion criteria prevent from participating
Afferent pupillary defect, obvious and unequivocal
Anterior chamber IOL and rupture of posterior lens capsule
Anticipated laser photocoagulation for macular edema within 4 months after Day 1
Aphakic eyes with rupture of posterior lens capsule
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Ozurdex intravitreal injection (combination with monthly sham injection) administered at a 16 week interval beginning on Day 1 and ending at Week 16.

Group II

Experimental
Ranibizumab injection (combination with sham injections beginning on Day 1 and Week 16) administered at monthly intervals beginning Day 1 and ending at Week 20.

Group III

Experimental
Ozurdex intravitreal injection administered at 16 week intervals beginning on Day 1 and ending at Week 16 with an initial IV Ranibizumab injection administered at Day 1, then treated with Ranibizumab according to reinjection parameters assessed monthly (in combination with sham if reinjection parameters are not met). Reinjection Parameters: 10 letter drop from best corrected visual acuity or a 100 µm increase in central retinal thickness according to optical coherence tomography (Spectralis HRA + OCT).

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Recruiting

Retina Vitreous Associates Medical Group

Beverly Hills, United StatesOpen Retina Vitreous Associates Medical Group in Google Maps
Recruiting

Retina Associates

Lakeland, United States
Recruiting

Center for Retina and Macular Disease

Winter Haven, United States
Recruiting

Valley Retina Institute, PA

Harlingen, United States
Suspended5 Study Centers