Retinal Vein Occlusion Clinical Trial
Official title:
The Standard Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study: Two Randomized Trials to Compare the Efficacy and Safety of Intravitreal Injection(s) of Triamcinolone Acetonide With Standard Care to Treat Macular Edema
The SCORE Study will compare the effectiveness and safety of standard care to intravitreal injection(s) of triamcinolone for treating macular edema (swelling of the central part of the retina) associated with central retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO).
Macular edema is a major cause of vision loss in patients with CRVO and BRVO. Both CRVO and
BRVO are common retinal problems and are caused by a blockage in one of the large retinal
veins (central retinal vein occlusion - CRVO) or smaller retinal veins (branch retinal vein
occlusion - BRVO). Currently, there is no effective treatment for macular edema associated
with CRVO and standard care treatment is observation. Grid laser photocoagulation may be
effective for some patients for macular edema associated with BRVO, but many patients derive
limited benefit from this treatment. Therefore, the development of new treatment modalities
for macular edema caused by these two conditions is an important research goal.
Over the last several years, many patients with macular edema from CRVO and BRVO have been
treated with an injection of a type of steroid called triamcinolone directly into the eye.
This type of injection is called an intravitreal injection. The triamcinolone preparation
commonly injected into the eye is Kenalog and is FDA-approved only for use in muscles and
joints. The SCORE Study will use a formulation of triamcinolone made specifically for the
eye.
The SCORE Study is a multicenter, randomized, Phase III trial to compare the effectiveness
and safety of standard care versus triamcinolone injection(s) for the treatment of macular
edema associated with CRVO and BRVO. In each of the two disease areas, 630 participants will
be randomized (similar to a flip of a coin) in a 1:1:1 ratio to one of three groups: standard
care, intravitreal triamcinolone 4 mg, or intravitreal triamcinolone 1 mg. After
randomization, participants will be examined every 4 months through 3 years to collect
ophthalmic information, including visual acuity, intraocular pressure, optical coherence
tomography, and fundus photography . Fluorescein angiography will be performed at 4, 12 and
24 months. Repeat intravitreal injections of triamcinolone and repeat laser treatment will be
provided as clinically indicated based on protocol-specific guidelines.
The primary outcome is improvement by 15 or more letters from baseline in best-corrected
ETDRS visual acuity score at the 12-month visit. Secondary outcomes include changes from
baseline in best-corrected ETDRS visual acuity score, changes in retinal thickness as
assessed by stereoscopic color fundus photography and optical coherence tomography, and
adverse ocular outcomes.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06262737 -
Single-center Study Measuring OSDI Dry Eye Score in Patients Undergoing an Anti-VEGF Induction Protocol
|
||
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 | |
Recruiting |
NCT05133791 -
NIR Fluorescence Molecular Imaging of ANXV-800CW in RVO Patients
|
Phase 1 | |
Withdrawn |
NCT04011358 -
Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
|
N/A | |
Completed |
NCT02898480 -
Changes in the Diameter of Retinal Vessels After Remote Ischemic Conditioning
|
N/A | |
Recruiting |
NCT01581151 -
Ozurdex With Rescue Lucentis for Treating Macular Edema Secondary to Retinal Vein Occlusion
|
N/A | |
Completed |
NCT01428388 -
Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion
|
N/A | |
Completed |
NCT00970957 -
Safety and Effectiveness of Bevacizumab Intravitreal Injections in the Treatment of Macular Edema Secondary to Retinal Vein Occlusion
|
Phase 3 | |
Recruiting |
NCT04075695 -
Ultra-wide-field Fluorescein Angiography in Patients With Retinal Vein Occlusion
|
||
Recruiting |
NCT03525132 -
Study of the Retinal Vascularization by Laser Doppler Velocimetry Coupled With an Adaptive Optics Camera ( AO-LDV)
|
N/A | |
Recruiting |
NCT03762226 -
Influence of Systemic Parameters in Diabetic Macular Edema - LIPSIA Study
|
||
Recruiting |
NCT02257333 -
Retinal Thrombosis and Atherosclerosis
|
||
Recruiting |
NCT04140448 -
Ultra-wide-field Fluorescein Angiography in Patients With Macular Edema Secondary to Retinal Vein Occlusion
|
||
Active, not recruiting |
NCT05003258 -
Functional and Anatomical Outcomes of Dexamethasone Intra-vitreal Implant in Patients With Resistant Macular Edema Secondary to Retinal Vein Occlusion After Intravitreal Anti-VEGF Injection
|
N/A | |
Terminated |
NCT04707625 -
Vascular Endothelial Growth Factor (VEGF) Levels in Retinal Vein Occlusion (RVO) During Anti-VEGF Treatment
|
Phase 4 | |
Recruiting |
NCT04142164 -
Computer-based Tutorial and Automated Speech Recognition for Intravitreal Drug Injections
|
N/A | |
Completed |
NCT02523339 -
Study of Retinal Oxygenation in Central Retinal Vein Occlusion
|
||
Active, not recruiting |
NCT01449682 -
Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With Anti-VEGF Injections.
|
Phase 3 | |
Completed |
NCT01568021 -
Post Market Surveillance of OZURDEX® for Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO)
|
N/A | |
Terminated |
NCT01225146 -
Study of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion (RAVE2)
|
Phase 1 |