Macular Edema Clinical Trial
Official title:
Intravitreal Dexamethasone Implant for Persistent Macular Thickening and Edema After Vitrectomy for Epiretinal Membrane: A Pilot Study
This study seeks to evaluate the effect of the intravitreal 0.7mg dexamethasone implant on central macular thickness and visual acuity in those patients with persistent macular edema after pars plana vitrectomy for epiretinal membrane.
Macular edema is a relatively common occurrence after pars plana vitrectomy. Kim et al
described that 47% of eyes undergoing vitrectomy for epiretinal membrane, macular hole, or
vitreous hemorrhage had evidence of macular thickening on optical coherence tomography scan.1
Post-vitrectomy macular edema can limit potential visual acuity gain from removal of a
symptomatic epiretinal membrane. Typical treatment of post-operative macular edema consists
of topical non-steroidal anti-inflammatory drugs (NSAIDs) and topical corticosteroids;
however, there are still resistant cases with refractory macular thickening.
The dexamethasone intravitreal implant (Ozurdex; Allergan, Irvine, CA) is currently
FDA-approved for the treatment of posterior uveitis as well as macular edema secondary to
retinal vein occlusion and diabetic retinopathy. Furino et al reported a retrospective series
describing how a single injection of the 0.7mg dexamethasone intravitreal implant resulted in
a substantial increase in best-corrected visual acuity (BCVA) and a decrease in central
macular thickness (CMT) on spectral-domain optical coherence tomography (SD-OCT) in 8
patients with persistent macular thickening after pars plana vitrectomy for epiretinal
membrane. There has been no prospective study evaluating the efficacy of this pharmacologic
agent in this setting.
As such, the purpose of this study is to prospectively evaluate the effect of the
intravitreal 0.7mg dexamethasone implant on CMT and BCVA in those patients with persistent
macular edema after pars plana vitrectomy for epiretinal membrane.
The results of this study will help delineate whether the intravitreal dexamethasone implant
has efficacy in improving CMT and/or visual acuity in those patients with refractory macular
thickening after pars plana vitrectomy for epiretinal membrane.
;
| 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 |
NCT03660345 -
PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME
|
Phase 3 | |
| Completed |
NCT03660371 -
ILM Peeling in PDR Patients Undergoing PPV for VH
|
N/A | |
| 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 |
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 |
NCT00476593 -
Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications
|
N/A | |
| Completed |
NCT00411970 -
20- Versus 23- Gauge System for Pars Plana Vitrectomy
|
Phase 4 | |
| Completed |
NCT00668239 -
Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser
|
N/A | |
| Terminated |
NCT01939691 -
Macular Edema Nepafenac vs. Difluprednate Uveitis Trial
|
Phase 4 |