Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF

Dexamethasone Intravitreal Implant for Retinal Vein Occlusion Associated Macular Edema After Treatment Failure With Anti-VEGF Medications

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01946399

Enrollment

Registered

2013-09-19

Start date

2013-09-30

Completion date

2017-09-01

Last updated

2017-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Edema, Retinal Vein Occlusion (RVO)

Brief summary

To determine if Ozurdex implant can offer an effective treatment for macular edema associated with retinal vein occlusion when treatment with intravitreal Avastin, Lucentis, or Eylea have not demonstrated a significant response.

Detailed description

To determine whether Ozurdex implant can offer an efficacious alternative for treatment of macular edema in the setting of retinal vein occlusion when treatment with intravitreal bevacizumab (Avastin),ranibizumab (Lucentis), and/or aflibercept (Eylea) have not demonstrated significant response.

Interventions

DRUGOzurdex implant

Intravitreal injection of Dexamethasone implant

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

All patients with Retinal Vein Occlusion (RVO) with available initial imaging and documented treatment failure with bevacizumab, ranibizumab, or aflibercept. Treatment failure is defined as lack of anatomic improvement (persistent intraretinal cystic changes/macular edema with central subfield thickness greater than 250 microns on time-domain OCT or greater than 275 microns on spectral domain OCT) with lack of visual improvement (less than 2 lines of visual gain by Snellen acuity), despite 3 to 6 intravitreal anti-VEGF treatments over the preceding 6 months.

Exclusion criteria

* Co-existing or pre-existing macular degeneration, diabetic macular edema, or other confounding disease processes * Interval surgical intervention, such as cataract surgery, that may confound visual outcomes. * Pregnancy * Coexisting conditions that would represent relative or absolute contraindications usage of ozurdex implant, including: * Ocular or periocular infections (including viral disease of the cornea and conjunctiva such as active epithelial herpes simplex keratitis, vaccinia, varicella, mycobacterial infection, and fungal diseases) * Advanced glaucoma * Aphakic eyes with rupture or missing posterior lens capsule * Eyes with anterior chamber intraocular lens and missing posterior lens capsule * Patients with known hypersensitivity to components of this product

Design outcomes

Primary

Measure	Time frame
Improvement in best-corrected Snellen visual acuity following initiation of Ozurdex therapy	6 Months

Secondary

Measure	Time frame
Anatomic/angiographic improvement in macular edema as evaluated by OCT and fluorescein angiography	6 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026