Macular Edema Clinical Trial
Official title:
Suprachoroidal Triamcinolone Acetonide for the Treatment of Macular Edema Associated With Retinal Vein Occlusion: A Pilot Study
This prospective non-randomized open-label interventional study aimed to evaluate feasibility in regard to potential efficacy and safety of triamcinolone acetonide (TA) injected in the suprachoroidal space (SCS) as a promising therapeutic route that provides a better bioavailability, longer sustained duration of action, and thus improved patients' compliance for the treatment of macular edema due to retinal vein occlusion (RVO).
Management of Macular Edema (ME) associated with Retinal Vein Occlusion (RVO) still poses a therapeutic challenge taking into account its complicated etiopathogenesis. Despite improved visual and anatomical outcomes achieved by intravitreal injections of antiangiogenics and steroids, these treatments are still associated with non-responders, tachyphylaxis, rebound phenomenon, high re-injection, and adverse events rates, which underscore the importance of addressing new approaches to formulate treatment strategies. Delivery of therapeutic agents into the suprachoroidal space (SCS) provides a novel alternative approach that has theoretical appeal, as it dominantly targets chorioretinal tissues with the posterior and circumferential spread of the drug administered while relatively sparing the unaffected anterior segment of the eye and the vitreous chamber, thus minimizing risks associated with off-target effects, which potentiates safety. This was well translated in preclinical and clinical studies through microinjector, which has been shown to provide a safe, minimally invasive, and reliable method of targeting SCS. In addition, sustained duration and favorable pharmacokinetics have been observed for small molecule suspensions including Triamcinolone Acetonide (TA), with the potential to reduce treatment burden. ;
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 | |
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 | |
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 |