Lucentis in Advanced Macular Degeneration

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Stanford University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Genentech
California Pacific Medical Center
Pacific Eye Associates
Information provided by (Responsible Party):
Steven R. Sanislo, Stanford University
ClinicalTrials.gov Identifier:
NCT00896779
First received: May 8, 2009
Last updated: April 30, 2012
Last verified: April 2012
  Purpose

Patients with low vision (visual acuity 20/400 or worse) were excluded from the large Phase III ranibizumab clinical trials. It is not known if treatment with ranibizumab results in improved visual function in such patients.Since ranibizumab has been shown to be the most effective therapy for exudative macular degeneration we propose to treat all patients in this study with monthly ranibizumab intravitreal injections.

Patients will be assigned to one of two groups by the flip of a coin. Group #1 for "heads" and Group #2 for "tails".

Group #1 patients will be treated for 3 monthly injections of 0.5 mg of ranibizumab and then as needed therapy.

Group #2 will be treated with 6 monthly injections of 0.5 mg of ranibizumab and then as needed therapy.


Condition Intervention Phase
Macular Degeneration
Drug: ranibizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lucentis in Advanced Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Mean change in VA from baseline to 12 months [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: October 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
ranibizumab Group 1
Group 1: 3 monthly injections of 0.5mg then prn
Drug: ranibizumab

Group 1 - 0.5mg intravitreal injection every month for 3 months then as needed for 12 months

Group 2 -0.5mg intravitreal injection every month for 6 months then as needed for 12 months

Other Name: Lucentis
ranibizumab Group 2
Group 2: 6 monthly injections of 0.5 mg then prn
Drug: ranibizumab

Group 1 - 0.5mg intravitreal injection every month for 3 months then as needed for 12 months

Group 2 -0.5mg intravitreal injection every month for 6 months then as needed for 12 months

Other Name: Lucentis

Detailed Description:

The duration of the study is up to 13 months. This includes up to 30 days during which tests will be performed before treatment. Only one eye will be chosen for the study. Patients can receive up to 12 injections of ranibizumab during this study (the first dose[s], plus additional doses [re treatment as often as every 22 days] if the doctor determines that additional doses are required).

In addition to study drug injections. Several eye examinations and procedures will be performed to evaluate response to treatment. These include: visual acuity testing (eye chart), contrast sensitivity testing, reading speed testing, measurement of time to complete typical daily activities, measurement of the thickness of the central retina, measurement of your central visual field.

On the screening visit and two more times during the study fluorescein angiography will be performed.

The screening tests included the following:

  • A review of your medical history
  • A review of any medications you are or have been taking
  • Eye examinations, including visual acuity testing (reading letters on an eye chart)
  • Blood pressure measurement Woman of childbearing potential must also take a urine pregnancy test during the screening period to rule out pregnancy.

Upon completion of the study at Month 12 and if it were to occur; early termination visit, the following procedures will be performed: vision exam,OCT,microperimetry,FA/Photos,VFQ,reading performance, contrast sensitivity and TIADL.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Subjects will be eligible if the following criteria are met:

  • Ability to provide written informed consent and comply with study assessments for the full duration of the study.
  • Age > 50 years.
  • Low vision AMD patients with a VA of 20/400 or worse.
  • Evidence of active exudation as manifested by subretinal or intraretinal fluid on OCT or fresh appearing subretinal hemorrhage on fundus examination.

Exclusion Criteria:

Subjects who meet any of the following criteria will be excluded from this study:

  • 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.
  • Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
  • Participation in another simultaneous medical investigation or trial.
  • Concurrent eye disease in the study eye that could compromise visual acuity (e.g., diabetic retinopathy, advanced glaucoma).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896779

Locations
United States, California
California Pacific Medical Center
San Francisco, California, United States, 94107
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Steven R. Sanislo
Genentech
California Pacific Medical Center
Pacific Eye Associates
Investigators
Principal Investigator: Dr. Steven R. Sanislo Stanford University
  More Information

No publications provided

Responsible Party: Steven R. Sanislo, MD/PI, Stanford University
ClinicalTrials.gov Identifier: NCT00896779     History of Changes
Other Study ID Numbers: SU-04202009-2338
Study First Received: May 8, 2009
Last Updated: April 30, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 23, 2014