Macular Edema Clinical Trial
Official title:
Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma
To evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex) and compare it with safety and efficacy of intravitreal bevacizumab in eyes with macular edema after plaque radiotherapy of uveal melanoma.
Plaque radiotherapy is a commonly used method for treatment of small and medium-sized uveal
melanomas. Macular edema is one of the most common causes of visual loss after plaque
radiotherapy and has been reported in up to 70% of patients with posterior uveal melanoma.
Different methods have been proposed for treatment of post-radiation macular edema and
include periocular steroid, intravitreal steroid, intravitreal vascular endothelial growth
factor (VEGF) inhibitors, photodynamic therapy, and macular laser photocoagulation.
Injection of intravitreal triamcinolone (a form of steroid) has been found to be useful for
treatment of different forms of macular edema but is associated with considerable rates of
increased intraocular pressure (glaucoma). Dexamethasone is more potent than triamcinolone
and can be safely injected directly into the vitreous cavity (intravitreal injection) but
unfortunately its use in the form of intravitreal injection is not practical due to the short
half-life of intraocular dexamethasone (about 3 hours).
Within the past several years, tiny drug delivery systems have been developed that allow
sustained release of minute amounts of steroid into the back part (vitreous cavity) of the
eye, when they are implanted into the vitreous cavity. Ozurdex is a biodegradable
dexamethasone intravitreal implant that has been shown to be well-tolerated and effective for
up to 6 months in reducing vision loss and improving visual outcome in eyes with different
types of macular edema including those secondary to diabetic retinopathy and retinal vein
occlusion.
In this study the investigators would like to evaluate the safety and effectiveness of
Ozurdex (dexamethasone intravitreal implant) for treatment of macular edema developing after
plaque radiotherapy of uveal melanoma.
;
| 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 | |
| Terminated |
NCT00918554 -
Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis
|
Phase 4 | |
| 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 | |
| Completed |
NCT00970957 -
Safety and Effectiveness of Bevacizumab Intravitreal Injections in the Treatment of Macular Edema Secondary to Retinal Vein Occlusion
|
Phase 3 | |
| 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 |