Central Retinal Vein Occlusion Clinical Trial
Official title:
Objective Measurement of Retinal Ischemia in Central Retinal Vein Occlusion, and the Effects of Treatment With a Vascular Endothelial Growth Factor Inhibitor.
Recent studies have shown a remarkably positive effect of 6 monthly injections of
Ranibizumab on eyes with CRVO. The disease may cause severe sight threatening complications,
partly due to restrictions in blood flow and oxygenation . Although Ranibizumab has been
shown affective to reduce oedema of the retina, it is not known whether the drug ameliorates
or aggravates restrictions in oxygenation.
The Oxymap oximeter allows a non-invasive measurement of the oxygen saturation in retinal
vessels and thus the state of retinal oxygenation.
The primary objective of the study is to evaluate the effects of injections of Ranibizumab
on the retinal oxygen saturation in eyes with newly diagnosed central retinal vein occlusion
(CRVO),
The secondary objective is to evaluate the effects of injections of Ranibizumab on visual
acuity and retinal oedema in eyes with different degree of ischemia.
Background and objectives
The CRUISE study has shown a remarkable positive effect of 6 monthly injections intravitreal
Ranibizumab on visual function in eyes with macular edema secondary to CRVO. Eyes with CRVO
are at risk of severe complications to retinal ischemia, particularly proliferative
retinopathy and neovascular glaucoma. It is not known whether intravitreal anti-VEGF therapy
ameliorates or aggravates retinal ischemia and thus the risk of ischemic complications is
unknown. Since complications to retinal ischemia take time to develop, and are relatively
infrequent, the CRUISE study was not designed, or powered, to investigate the impact of
intravitreal anti-VEGF treatment on these complications.
The Oxymap oximeter allows objective non-invasive measurement of the oxygen saturation in
retinal vessels and thus the degree of retinal ischemia. The rationale behind the present
study is to use this instrument in order to obtain preliminary information on the effects of
intravitreal anti-VEGF treatment on retinal ischemia in CRVO eyes without having to wait for
ischemic complications to arise in a large study population.
The primary objective of the study is to evaluate the effects of treatment with intravitreal
Ranibizumab on the retinal oxygen saturation in eyes with newly diagnosed central retinal
vein occlusion (CRVO),
The secondary objective is to evaluate the effects of intravitreal Ranibizumab on visual
acuity and central retinal thickness in eyes with different degree of ischemia.
Study design
The research project is a case-series study of CRVO-patients with three monthly injections
of Ranibizumab and a 3 month follow-up period, during which Ranibizumab injections are
provided as needed.
;
Observational Model: Case-Only, Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02390245 -
Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study
|
N/A | |
Completed |
NCT01969708 -
Study of Comparative Treatments for Retinal Vein Occlusion 2 (SCORE2)
|
Phase 3 | |
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 | |
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 |
NCT03981549 -
Treatment of Central Retinal Vein Occlusion Using Stem Cells Study
|
Phase 1/Phase 2 | |
Completed |
NCT02274259 -
Comparing Injection Frequency Between Aflibercept and Ranibizumab in Patients With CRVO With a Treat& Extend Regimen
|
Phase 4 | |
Not yet recruiting |
NCT00383773 -
Retinal Endo Vascular Surgery for Central Retinal Vein Occlusion
|
N/A | |
Completed |
NCT00952614 -
A Study of a Sustained Release Fluocinolone Implant for Treatment of Central Retinal Vein Occlusion
|
N/A | |
Recruiting |
NCT04601701 -
Central Retinal Vein Occlusion (CRVO) Treatment With Bevacizumab and Dexamethasone or Bevacizumab Only.
|
N/A | |
Withdrawn |
NCT03417401 -
Surgical Stabilizer Assisted RVC With rtPA for CRVO
|
Phase 1 | |
Completed |
NCT01976312 -
Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Central Retinal Vein Occlusion (CRVO)
|
Phase 3 | |
Completed |
NCT01724554 -
Impact of Intravitreal Aflibercept Injections on Capillary Non-Perfusion
|
Phase 1/Phase 2 | |
Completed |
NCT01471691 -
Intravitreal Ranibizumab 0.5MG, or 1.0mg for RVO With Macular Edema Previously Receiving Bevacizumab
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT01011374 -
Impact of Lucentis on Psychological Morbidity in Patients With Retinal Vein Occlusion
|
Phase 1 | |
Completed |
NCT03223714 -
Conbercept Ophthalmic Injection for Patients of Central Retinal Vein Occlusion
|
Phase 3 | |
Recruiting |
NCT01827722 -
Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein Occlusion
|
Phase 4 | |
Completed |
NCT00906685 -
Bevacizumab for Central Retinal Vein Occlusion Study
|
Phase 3 | |
Active, not recruiting |
NCT04793100 -
Spontaneous Retinal Artery Pulses (SPARs) as a Prognostic Determinant of Central Retinal Vein Occlusions (CRVO) in Patients With or Without Intravitreal Aflibercept Injections
|
N/A | |
Recruiting |
NCT02405741 -
Hyperbaric Chamber for Central Retinal Vein Occlusion (CRVO) Patients
|
Phase 2 | |
Recruiting |
NCT01348633 -
Retinal Oxygen Saturation, Blood Flow, Vascular Function and High Resolution Morphometric Imaging in the Living Human Eye
|
N/A |