Evaluation of the Effect of Vitreous Composition Determined by Ultrasound and Optical Coherence Tomography (OCT) on Ranibizumab Therapy

NCT01256632 | Completed

• 1 other identifier: FVF4316s
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective: \*To measure the difference in the number of Ranibizumab therapies needed in 12 months in the Posterior Vitreous Detachment (PVD) positive and Posterior Vitreous Detachment (PVD) negative group. Secondary Objective:

• To measure the mean change in visual acuity from Baseline to Month 12.
• To measure the mean change in central retinal thickness per OCT from Baseline to Month 12

Conditions

Choroidal Neovascularization

Outcome Measures

Primary Outcomes (1)

• Difference in the number of Ranibizumab therapies needed in 12 months in the Posterior Vitreous Detachment positive and Posterior Vitreous Detachment negative group

  12 months

Secondary Outcomes (1)

• Mean change in visual acuity from Baseline to Month 12

  12 Months

Study Arms (2)

Subfoveal CNV, secondary to AMD with PVD

ACTIVE COMPARATOR

20 eyes with Subfoveal Choroidal Neovascularization, secondary to Age Related Macular Degeneration, with Posterior Vitreous Detachment (PVD Positive). All study eyes will receive 0.5mg, of intravitreous monthly injections of Ranibizumab, for four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits monthly for 12 months. Re-treatment after.

Drug: Ranibizumab

Subfoveal CNV, secondary to AMD w/o PVD

ACTIVE COMPARATOR

20 eyes with Subfoveal Choroidal Neovascularization, secondary to Age Related Macular Degeneration, without Posterior Vitreous Detachment (PVD Negative). All study eyes will receive 0.5mg, of intravitreous monthly injections of Ranibizumab, for four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits monthly for 12 months. Re-treatment after the first 4 injections, will be on an as needed basis, based on predefined criteria.

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

All study eyes will receive 0.5mg, of intravitreous monthly injections of ranibizumab, for four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits monthly for 12 months. Re-treatment after.

Also known as: Lucentis

Subfoveal CNV, secondary to AMD w/o PVD; Subfoveal CNV, secondary to AMD with PVD

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• 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 greater than or equal to 50 years
• Best corrected visual acuity in the study eye between 20/25 and 20/320
• Subfoveal choroidal neovascularization, secondary to age related macular degeneration
• Total lesion size less than 4 disc diameters
• Any subretinal hemorrhage must comprise no more than 50% of total lesion size.
• Clear ocular media and adequate papillary dilation to permit good quality stereoscopic fundus photography
• 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.
• Patients with any form of prior eye treatment for AMD including: Photodynamic Therapy, anti-VEGF Therapy, Laser, Vitreoretinal surgery
• Had ocular surgery within the past 60 days in study eye
• Concurrent use of more than two therapies for glaucoma
• Uncontrolled glaucoma in the study eye(defined as intraocular pressure\>30mm Hg despite treatment with anti-glaucoma medication)
• Concurrent use of systemic anti-VEGF agents
• Has active infection in the study eye(s)
• Inability to obtain photographs to document CNV
• Has received investigational therapy within 60 days prior to study entry
• Patients with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
• Has an allergy to sodium fluorescein dye
• Inability to comply with study or follow-up procedures

Sponsors & Collaborators

• Vision Research Foundation: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Vision Research Foundation

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Choroidal Neovascularization

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Michael T Trese, MD

  Vision Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DIrector of the Vision Research Foundation

Study Record Dates

• First Submitted: December 2, 2010
• First Posted: December 8, 2010
• Study Start: October 1, 2007
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: June 28, 2012

Record last verified: 2012-06

Locations

US (1)