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Completed

NCT Number: NCT01027481

Ranibizumab in Patients With Branch Retinal Vein Occlusion

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.

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Key information

Conditions

Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vienna General Hospital

Vienna, 1090, Austria

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lucentis

Drug

intravitreally administration of 0.05 ml Lucentis

Other names: RANIBIZUMAB (Lucentis 0.05 ml, Novartis)

Primary outcomes

  1. Main outcome measure: Retinal vessel diameters

    Time frame: 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.

    Time frame: weeks 1,4 and16

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 8, 2009
Registry last updated
Dec 8, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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