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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Michael T. Trese, M.D., Vision Research Foundation
ClinicalTrials.gov Identifier:
NCT01256632
First received: December 2, 2010
Last updated: June 26, 2012
Last verified: June 2012
  Purpose

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

Condition Intervention
Choroidal Neovascularization
Drug: Ranibizumab

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Evaluation of the Effect of Vitreous Composition Determined by Ultrasound and Optical Coherence Tomography (OCT) on Ranibizumab Therapy

Resource links provided by NLM:


Further study details as provided by Vision Research Foundation:

Primary Outcome Measures:
  • Difference in the number of Ranibizumab therapies needed in 12 months in the Posterior Vitreous Detachment positive and Posterior Vitreous Detachment negative group [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change in visual acuity from Baseline to Month 12 [ Time Frame: 12 Months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: October 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Subfoveal CNV, secondary to AMD with PVD
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
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.
Other Name: Lucentis
Active Comparator: Subfoveal CNV, secondary to AMD w/o PVD
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
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.
Other Name: Lucentis

Detailed Description:

This is an open-label study, of intravitreally administered Ranibizumab in eyes with Age-related Macular Degeneration (AMD), specifically looking at the correlation between the presence of Posterior Vitreous Detachment(PVD) and the number of intravitreal injections of Ranibizumab required. 40 subjects from the offices of Vision Research Foundation will be enrolled in this study. Subjects will be assigned to either a Posterior Vitreous Detachment (PVD) positive group or a Posterior Vitreous Detachment (PVD) negative group based on a pre-treatment ultrasound. A maximum of 20 subjects in each group will be enrolled. Subject accrual into the trial is expected to be completed within 6 months.

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. Eyes will be evaluated with a full ocular examination, visual acuity measurement (ETDRS chart at a distance of 4 meters),OCT,FA,Fundus Photos, B-scan Ultrasound and subject adverse event monitoring.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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 other conditions the investigator considers to be sound reasons for exclusion(e.g., lack of motivation, history of poor compliance, concomitant illnesses, personality disorder, mental condition, drug abuse, use of neuroleptics, physical or social condition predicting difficulty in long-term follow-up).
  • Has an allergy to sodium fluorescein dye
  • Inability to comply with study or follow-up procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01256632

Locations
United States, Michigan
Vision Research Foundation
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
Vision Research Foundation
Genentech
Investigators
Principal Investigator: Michael T Trese, MD Vision Research Foundation
  More Information

No publications provided

Responsible Party: Michael T. Trese, M.D., DIrector of the Vision Research Foundation, Vision Research Foundation
ClinicalTrials.gov Identifier: NCT01256632     History of Changes
Other Study ID Numbers: FVF4316s
Study First Received: December 2, 2010
Last Updated: June 26, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Neovascularization, Pathologic
Choroidal Neovascularization
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on July 28, 2014