Ranibizumab in Patients With Branch Retinal Vein Occlusion

Retinal Vein Occlusion Clinical Trial

Official title:

Response of Retinal Vessels to Anti Vascular Endothelial Growth Factor (VEGF) Treatment in Patients With Branch Retinal Vein Occlusion (BRVO)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01027481
• Other study ID #: V1
• Status: Completed
• Phase: Phase 4
• First received: December 7, 2009
• Last updated: December 7, 2009
• Start date: December 2007
• Est. completion date: December 2009

Study information

• Verified date: November 2007
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

In a recent study we could show that the early retinal venous vasoconstriction after grid photocoagulation in branch retinal vein occlusion (BRVO) is closely correlated to the visual outcome after three months. This could be of clinical importance, because the degree of vasoconstriction might be an early marker of treatment success, compatible with the idea that hypoxia is the major trigger of VEGF in BRVO. The present study evaluates the response of retinal vessel diameters to anti VEGF treatment with lucentis in patients with BRVO. This is done in an effort to gain insight into the retinal hemodynamic consequences of anti VEGF treatment in BRVO. The hypothesis that anti VEGF treatment is associated with a vasoconstrictor response in retinal vessel in patients with BRVO is tested.

Description:

To investigate the response of retinal vessel diameters to lucentis treatment in patients with BRVO and to correlate these changes with changes in functional outcome after 3 months.

Pilot study in patients scheduled for intravitreal anti-VEGF (Lucentis™) treatment with BRVO

30 patients with BRVO scheduled for intravitreal anti-VEGF treatment Intravitreous administration of Ranibizumab (Lucentis ™)

Main outcome measure: Retinal vessel diameters

Secondary outcome measures: Retrobulbar flow velocities, best-corrected visual acuity, macular sensitivity assessed with Microperimetry, objective functional response assessed with mfERG, anatomic changes in the macula region as assessed with StratusOCT and prototype of a Cirrus-OCT(which is available at the Department of Ophthalmology, Medical University of Vienna), angiographical outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• male or female, at least 18 years of age.

• ophthalmoscopic evidence of recent BRVO, that is, a history of 3 months.

• macular edema secondary to BRVO in the study eye scheduled for intravittreal anti-VEGF as primary treatment.

• retinal thickness of > 300 µm by OCT in the central subfield of the study eye at baseline.

• VA decrease attributable to the edema.

• written informed consent has been obtained.

• female patients of childbearing potential must have a negative urine pregnancy test.

Exclusion Criteria:

• Uncontrolled sytemic disease

• Symptoms of a clinically relevant illness in the 3 weeks before the first study day

• Any ocular condition that in the opinion of the investigator would prevent a 15-letter improvement in visual acuity (eg severe macular ischemia)

• History of glaucoma, aphakie or presence of anterior chamber intraocular lens, active reinal neovascularisation, choroidal neovascularisation, significant cataract, presence of rubeosis iridis, any ocular infection, history of pars plana vitrectomy, anticipated need for ocular surgery in the study eye during the study perios.

• contraindication to pupil dilation known allergy or contraindication to the use of fluorescein.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinal Vein Occlusion

Intervention

Drug:
• Lucentis
intravitreally administration of 0.05 ml Lucentis

Locations

Country	Name	City	State
Austria	Vienna General Hospital	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Main outcome measure: Retinal vessel diameters		weeks 1, 4 and 16	No
Secondary	Secondary outcome measures: Retrobulbar flow velocities, best-corrected visual acuity, macular sensitivity, objective functional response, anatomic changes in the macula region, angiographical outcomes.		weeks 1,4 and16	Yes