Ranibizumab in Patients With Branch Retinal Vein Occlusion

This study has been completed.
Sponsor:
Information provided by:
Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01027481
First received: December 7, 2009
Last updated: NA
Last verified: November 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Retinal Vein Occlusion
Drug: Lucentis
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Response of Retinal Vessels to Anti Vascular Endothelial Growth Factor (VEGF) Treatment in Patients With Branch Retinal Vein Occlusion (BRVO)

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Main outcome measure: Retinal vessel diameters [ Time Frame: weeks 1, 4 and 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary outcome measures: Retrobulbar flow velocities, best-corrected visual acuity, macular sensitivity, objective functional response, anatomic changes in the macula region, angiographical outcomes. [ Time Frame: weeks 1,4 and16 ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: December 2007
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Lucentis
    intravitreally administration of 0.05 ml Lucentis
    Other Name: RANIBIZUMAB (Lucentis 0.05 ml, Novartis)
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01027481

Locations
Austria
Vienna General Hospital
Vienna, Austria, 1090
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Stefan Sacu, Ass. Prof. Medical University of Vienna
  More Information

No publications provided by Medical University of Vienna

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stefan Sacu, Ass. Professor, Department of Ophthalmology, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01027481     History of Changes
Other Study ID Numbers: V1
Study First Received: December 7, 2009
Last Updated: December 7, 2009
Health Authority: Austria: Agency for Health and Food Safety

Keywords provided by Medical University of Vienna:
lucentis, macular edema, branch retinal vein occlusion

Additional relevant MeSH terms:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Endothelial Growth Factors
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014