Ranibizumab in Patients With Branch Retinal Vein Occlusion

NCT01027481 | Completed Phase 4

• 1 other identifier: V1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Retinal Vein Occlusion

Keywords

lucentis, macular edema, branch retinal vein occlusion

Outcome Measures

Primary Outcomes (1)

• Main outcome measure: Retinal vessel diameters

  weeks 1, 4 and 16

Secondary Outcomes (1)

• 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

Interventions

Lucentis DRUG

intravitreally administration of 0.05 ml Lucentis

Also known as: RANIBIZUMAB (Lucentis 0.05 ml, Novartis)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Vienna General Hospital

Vienna, 1090, Austria

Location

Related Publications (1)

• Sacu S, Pemp B, Weigert G, Matt G, Garhofer G, Pruente C, Schmetterer L, Schmidt-Erfurth U. Response of retinal vessels and retrobulbar hemodynamics to intravitreal anti-VEGF treatment in eyes with branch retinal vein occlusion. Invest Ophthalmol Vis Sci. 2011 May 9;52(6):3046-50. doi: 10.1167/iovs.10-5842.

  PMID: 21051706 DERIVED

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema

Interventions

Ranibizumab; lactitol

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Stefan Sacu, Ass. Prof.

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 7, 2009
• First Posted: December 8, 2009
• Study Start: December 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: December 1, 2009
• Last Updated: December 8, 2009

Record last verified: 2007-11

Locations

AU (1)