Posterior Vitreous Detachment (PVD) Assessment During Dual Retinal Vein Occlusion (RVO) Lucentis Evaluations

NCT00831350 | Completed Phase 2

• 2 other identifiers: FVF4348s09-0049
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study of subjects with retinal vein occlusion (RVO) specifically looking at the difference in outcomes between patients with posterior vitreous detachment (PVD) and those without PVD. Posterior vitreous detachment is a condition where the gel-like substance that occupies the space between the retina and the lens of the eye liquefies and separates from the retina. 20 subjects from Barnes Retina Institute will be enrolled in this study. Based on a pre-treatment ultrasound (a test utilizing high-frequency sound waves to look at the inside of the eye), high resolution OCT (a noninvasive procedure called optical coherence tomography to check the thickness of your retina) and clinical exam, subjects will be assigned to one of 2 groups at baseline: Group 1 will be those with PVD and Group 2 will be those without PVD. Then subjects will receive monthly intravitreal (inside the eye) injections of Ranibizumab.

Conditions

Retinal Vein Occlusion; Posterior Vitreous Detachment

Keywords

RVO; PVD

Outcome Measures

Primary Outcomes (1)

• Mean change in BCVA at 6 months in the PVD positive and PVD negative ranibizumab-treated groups.

  6 months

Secondary Outcomes (2)

• To measure the mean change in central retinal thickness per OCT from baseline to Month 6 in PVD (+) and PVD (-) patients.

  6 months

• To measure the mean change in leakage as determined by FA from baseline to Month 6 in PVD (+) and PVD (-) patients.

  6 months

Study Arms (1)

ranibizumab

EXPERIMENTAL

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

Subjects will receive study medication ranibizumab 0.5mg. Re-treatment will occur monthly through 6 injections

Also known as: Lucentis

ranibizumab

Eligibility Criteria

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

You may qualify if:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study
• Subjects of either gender, Age \> 18 years
• Best corrected visual acuity in the study eye between 20/40 and 2/200 inclusive.
• Retinal venous occlusive disease (BRVO or CRVO)
• Clear ocular media and adequate papillary dilation to permit good quality stereoscopic fundus photography, scheimpflug photography and high resolution OCT
• Ability to return for all study visits

You may not qualify if:

• Pregnancy (positive pregnancy test) or lactation.
• Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
• Prior RVO in the study eye
• Duration of RVO greater than 6 months
• Laser photocoagulation for macular edema within 3 months of Day 0
• Patients prior eye treatment including anti-VEGF therapy (within 3 months) or, intravitreal corticosteroid therapy (within 6 months)
• Prior vitreoretinal surgery.
• Had ocular surgery within the past 60 days in the study eye.
• Concurrent use of more than two therapies for glaucoma.
• Uncontrolled glaucoma in the study eye (defined as intraocular pressure \>30 mm Hg despite treatment with anti-glaucoma medication).
• Neovascular glaucoma
• Concurrent use of systemic anti-VEGF agents
• Has active infection in the study eye.
• Inability to obtain photographs.
• Has received investigational therapy within 60 days prior to study entry.

Sponsors & Collaborators

• Barnes Retina Institute: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Barnes Retina Institute

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Retinal Vein Occlusion; Vitreous Detachment

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Nancy M Holekamp, MD

  Barnes Retina Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nancy M. Holekamp, MD

Model Details: BRVO and CRVO will be enrolled in this trial.

Study Record Dates

• First Submitted: January 27, 2009
• First Posted: January 28, 2009
• Study Start: April 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2012
• Last Updated: October 30, 2017

Record last verified: 2017-10

Locations

US (1)