Evaluation of OZURDEX® in Patients With Macular Edema Secondary to Retinal Vein Occlusion in China (NCT03908307) | Clinical Trial Compass
CompletedPhase 4
Evaluation of OZURDEX® in Patients With Macular Edema Secondary to Retinal Vein Occlusion in China
China150 participantsStarted 2019-07-25
Plain-language summary
This study will take place in China to evaluate the safety and efficacy of OZURDEX implant 700 μg in the treatment of macular edema due to retinal vein occlusion (RVO) in patients who have never received treatment for RVO.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Inclusion Criteria:
* Patient diagnosed with macular edema due to RVO (either BRVO or CRVO, non-ischemic)
* Retinal thickness ≥ 300 μm by SD-OCT in the central 1 mm macular subfield of the study eye at the Screening visit
* BCVA score of 19 to 73 letters (approximately 20/400 to 20/40 Snellen equivalent) in the study eye measured by ETDRS method at Screening
* \< 3 months of macular edema duration
* Treatment-naive patients (ie, have not previously received any treatment for macular edema secondary to RVO)
Exclusion Criteria:
* Uncontrolled systemic disease
* Presence of/history of any ocular condition other than macular edema that affects visual acuity (eg, cataract, severe macular ischemia, foveal atrophy, age-related macular degeneration, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass syndrome, prior macular detachment)
* Any of the following ≤ 3 months before study entry or anticipated need within the coming 3 months:
* Intraocular surgery
* Laser photocoagulation
* Intraocular injection
* Periocular steroid injection
* Vitrectomized eye
* Aphakic eyes with ruptured posterior lens capsule or presence of an ACIOL, iris or transscleral fixated intraocular lens
* History of marked IOP elevation in response to steroid treatment that (a) required IOP-lowering treatment, (b) resulted in a \>10 mm Hg increase in IOP from predose, or (c) resulted in IOP \>25 mm Hg
* History of glaucoma or ocular hypertension (IOP \> 21 mm H…
What they're measuring
1
Mean change in visual acuity from Baseline
Timeframe: At Month 6
2
Proportion of patients with a BCVA improvement of 15 letters or more compared to Baseline
Timeframe: At Month 6
3
BCVA average change from Baseline in area under the curve (AUC) analysis