Macular Edema Clinical Trial
Verified date | April 2016 |
Source | Allergan |
Contact | n/a |
Is FDA regulated | No |
Health authority | European Union: European Medicines Agency |
Study type | Observational |
This study is a multicenter, prospective, observational study to evaluate the long-term safety of OZURDEX® in patients with macular oedema following central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) or patients with non-infectious posterior segment uveitis in real-world clinical practice.
Status | Completed |
Enrollment | 875 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Macular oedema following either BRVO or CRVO or non-infectious uveitis - Requires treatment with OZURDEX® Exclusion Criteria: - Current participation in any clinical study |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Allergan |
France, Germany, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of Patients Reporting Serious Adverse Events | 2 years | No | |
Primary | Incidence of Patients Reporting Ophthalmic Adverse Events of Special Interest | The ophthalmic adverse events of special interest include: increased intraocular pressure, glaucoma, ocular hypertension, cataract formation and progression, vitreous detachment, haemorrhage, endophthalmitis (infectious/ non-infectious), retinitis secondary to reactivation of latent viral or other ophthalmic infections, retinal tear/detachment, significant vitreous leak or hypotony, systemic corticosteroid effects, and mechanical failure of device and implant misplacement. | 2 years | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04292912 -
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Participants With Diabetic Macular Edema
|
Phase 1 | |
Recruiting |
NCT05976139 -
Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies
|
N/A | |
Completed |
NCT03660371 -
ILM Peeling in PDR Patients Undergoing PPV for VH
|
N/A | |
Completed |
NCT03660345 -
PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME
|
Phase 3 | |
Completed |
NCT01660802 -
Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)
|
Phase 3 | |
Completed |
NCT01908816 -
An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.
|
Phase 3 | |
Completed |
NCT04592419 -
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)
|
Phase 3 | |
Completed |
NCT02867735 -
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema
|
Phase 1 | |
Completed |
NCT02623673 -
Simultaneous Therapy With Intravitreal Dexamethasone Implant and Bevacizumab for the Treatment of Macular Edema
|
N/A | |
Terminated |
NCT01946399 -
Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF
|
N/A | |
Completed |
NCT01428388 -
Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion
|
N/A | |
Completed |
NCT01231633 -
Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)
|
N/A | |
Recruiting |
NCT01023113 -
To Compare Visual Field Impairment in Conventional Double Frequency Nd: YAG Panretinal Photocoagulation With PASCAL Panretinal Photocoagulation
|
N/A | |
Completed |
NCT00970957 -
Safety and Effectiveness of Bevacizumab Intravitreal Injections in the Treatment of Macular Edema Secondary to Retinal Vein Occlusion
|
Phase 3 | |
Terminated |
NCT00969293 -
Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion
|
Phase 1 | |
Terminated |
NCT00918554 -
Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis
|
Phase 4 | |
Completed |
NCT00476593 -
Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications
|
N/A | |
Completed |
NCT00668239 -
Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser
|
N/A | |
Completed |
NCT00411970 -
20- Versus 23- Gauge System for Pars Plana Vitrectomy
|
Phase 4 | |
Terminated |
NCT01939691 -
Macular Edema Nepafenac vs. Difluprednate Uveitis Trial
|
Phase 4 |