Retinal Blood Flow in Response to an Intravitreal Injection of Ranibizumab for Central Retinal Vein Occlusion (CRVO)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Ranibizumab (Lucentis, Genentech) is an off-label drug used for the clinical treatment of central retinal vein occlusion, which is one of the most common retinal vascular disorders. Despite its clinical effectiveness, concerns remain regarding the systemic effects of the drug and previous studies have noted retinal arteriolar vasoconstriction following a ranibizumab injection. We aim to provide a physiological basis to these observations by assessing retinal blood flow before and after the ranibizumab injections. Specifically, we will assess the blood flow parameters (i.e. retinal vessel diameter, velocity \& flow) immediately before the first injection and post-injection over a follow-up continued treatment period.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lucentis for Central Retinal Vein Occlusion (CRVO)

NCT00406796

Central Retinal Vein Occlusion

COMPLETED PHASE1

Retinal Ischemia in Central Retinal Vein Occlusion, and the Effects of Treatment With Intravitreal Ranibizumab

NCT01360385

Central Retinal Vein Occlusion

COMPLETED

Intravitreal Ranibizumab Treatment of Central Retinal Vein Occlusion With Macular Edema

NCT00403039

Retinal Vein Occlusion

COMPLETED PHASE1

Impact of Lucentis on Psychological Morbidity in Patients With Retinal Vein Occlusion

NCT01011374

Venous Retinal Branch Occlusion Central Retinal Vein Occlusion Retinal Vein Occlusion +1 more

UNKNOWN PHASE1

Hemodilution Versus Ranibizumab in Early-onset Central Retinal Vein Occlusion

NCT01448018

Central Retinal Vein Occlusion

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Ranibizumab is an antibody fragment designed to inhibit the activity of Vascular Endothelial Growth Factor (VEGF), which is responsible for the neovascularization and retinal edema responsible for interference of normal vision in central retinal vein occlusion. However, VEGF has a role in the vasculature as a vasodilator where it alters the expression of tight junction proteins and upregulates the release of the vasodilator nitric oxide. Consequently, intravitreal ranibizumab injections could result in systemic inhibition of VEGF, leading to long-term retinal arteriolar vasoconstriction and potentially adverse cerebrovascular and myocardial accidents. Therefore, evaluating retinal blood flow would provide a physiological foundation to this concern and provide physicians with valuable information regarding the risks of continued ranibizumab therapy.

Given the role of VEGF as a vasodilator in the vasculature where it works to alter the expression of tight junction proteins and the production of vasoactive substances especially nitric oxide, inhibiting this molecule with ranibizumab could result in vasoconstriction in these vessels. We hypothesize that vasoconstriction and decreased retinal blood flow will be observed after an intravitreal injection of ranibizumab for treatment of central retinal vein occlusion.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Central Retinal Vein Occlusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anti-VEGF group

Patients who are clinically indicated for the intravitreal injection of ranibizumab

No interventions assigned to this group

Age-matched controls

Group of healthy participants who will be age and gender matched

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age \> 50 years
* central retinal vein occlusion scheduled for first intravitreal injection of ranibizumab as part of their clinical care

Exclusion Criteria

* previous history of intravitreal therapy,
* history of thromboembolic events,
* glaucoma or an intraocular pressure \>21 mmHg
* diabetes mellitus or altered blood viscosity syndromes
* blood donation in the previous 2 weeks
* refractive error of +/- 6.00 DS and/or 2.00 DC

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes