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Lucentis in Advanced Macular Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00896779
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : May 27, 2015
Last Update Posted : June 29, 2015
Sponsor:
Collaborators:
Genentech, Inc.
California Pacific Medical Center
Pacific Eye Associates
Information provided by (Responsible Party):
Steven R. Sanislo, Stanford University

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Macular Degeneration Drug: ranibizumab Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Lucentis in Advanced Macular Degeneration
Study Start Date : October 2009
Actual Primary Completion Date : September 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Mean Change in Visual Acuity [ Time Frame: 12 months ]
    Change in vision from baseline measurement at 12 months. Standard ETDRS chart (80 letters) was used to determine visual acuity with test luminance of 45 cd/m ^2 at 8 feet. Number of correctly read letters were reported.


Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00896779


Locations
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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, Inc.
California Pacific Medical Center
Pacific Eye Associates
Investigators
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Principal Investigator: Dr. Steven R. Sanislo Stanford University
More Information
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Responsible Party: Steven R. Sanislo, MD/PI, Stanford University
ClinicalTrials.gov Identifier: NCT00896779    
Other Study ID Numbers: SU-04202009-2338
First Posted: May 12, 2009    Key Record Dates
Results First Posted: May 27, 2015
Last Update Posted: June 29, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
 Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents