Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration

NCT01577381

Last updated date
Study Location
Scottsdale Medical Imaging
Phoenix, Arizona, 85016, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Age-Related Maculopathy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
60-90 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Men and women between the ages of 60 and 90 years.

- Diagnosis of a geographic atrophy (GA) secondary to dry Age-Related Macular Degeneration.

- Best Corrected Visual Acuity (BCVA) of 20/80 or better in the study eye

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Evidence of ocular disease other than geographic atrophy (GA) secondary to dry
Age-Related Macular Degeneration in the study eye.


- History or diagnosis of exudative (wet) Age-Related Macular Degeneration, with
subretinal or choroidal neovascular lesions in the study eye.


- Presence of disease or condition that might compromise the cardiovascular,
hematological, renal, hepatic, pulmonary, endocrine, central nervous, immune, or
gastrointestinal system

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Age-Related MaculopathyEfficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration
NCT01577381
  1. Phoenix, Arizona
  2. Phoenix, Arizona
  3. Phoenix, Arizona
  4. Tucson, Arizona
  5. Tucson, Arizona
  6. Tucson, Arizona
  7. Arcadia, California
  8. Arcadia, California
  9. Beverly Hills, California
  10. Beverly Hills, California
  11. Beverly Hills, California
  12. Mountain View, California
  13. Mountain View, California
  14. Pasadena, California
  15. Roseville, California
  16. Sacramento, California
  17. San Jose, California
  18. Santa Ana, California
  19. Santa Ana, California
  20. Santa Ana, California
  21. Santa Ana, California
  22. Santa Ana, California
  23. Altamonte Springs, Florida
  24. Altamonte Springs, Florida
  25. Altamonte Springs, Florida
  26. Lakeland, Florida
  27. Miami, Florida
  28. Miami, Florida
  29. Palm Beach Gardens, Florida
  30. West Palm Beach, Florida
  31. Leawood, Kansas
  32. Mission, Kansas
  33. Overland Park, Kansas
  34. Portland, Maine
  35. Portland, Maine
  36. Portland, Maine
  37. South Portland, Maine
  38. Toms River, New Jersey
  39. Toms River, New Jersey
  40. Toms River, New Jersey
  41. Brooklyn, New York
  42. East Setauket, New York
  43. Lynbrook, New York
  44. Lynbrook, New York
  45. Merrick, New York
  46. New York, New York
  47. New York, New York
  48. New York, New York
  49. Plainview, New York
  50. Rockville Centre, New York
  51. Valley Stream, New York
  52. Cincinnati, Ohio
  53. Mason, Ohio
  54. West Mifflin, Pennsylvania
  55. WestMifflin, Pennsylvania
  56. Columbia, South Carolina
  57. Columbia, South Carolina
  58. West Columbia, South Carolina
  59. West Columbia, South Carolina
  60. West Columbia, South Carolina
  61. Nashville, Tennessee
  62. Nashville, Tennessee
  63. Arlington, Texas
  64. Arlington, Texas
  65. Arlington, Texas
  66. Arlington, Texas
  67. Arlington, Texas
  68. Austin, Texas
  69. Austin, Texas
  70. Austin, Texas
  71. Austin, Texas
  72. Cedar park, Texas
  73. Edinburg, Texas
  74. Edinburg, Texas
  75. McAllen, Texas
  76. McAllen, Texas
  77. McAllen, Texas
  78. McAllen, Texas
  79. Weslaco, Texas
  80. Bellevue, Washington
  81. Bellevue, Washington
  82. Seattle, Washington
  83. Seattle, Washington
ALL GENDERS
60 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration
Official Title  ICMJE A Phase 2 Multi-center, Randomized, Double-masked, Placebo-controlled, Multi-dose Study To Investigate The Efficacy, Safety, Pharmacokinetics And Pharmacodynamics Of Rn6g (Pf-04382923) In Subjects With Geographic Atrophy Secondary To Age-related Macular Degeneration
Brief Summary The purpose of this study is to determine the efficacy, safety and tolerability of multiple doses of RN6G in subjects with Geographic Atrophy Secondary to Age-related Macular Degeneration.
Detailed Description The trial was terminated early on April 12, 2013 due to an organizational decision, which was not based on safety or efficacy concerns. Subjects who were already enrolled into the study were followed.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Age-Related Maculopathy
Intervention  ICMJE
  • Biological: RN6G
    Intravenous, 11 doses, 30 minute infusion, dose ranging from 2.5 mg/kg up to a maximum of 15 mg/kg
  • Biological: Placebo
    Intravenous, 11 doses, 30 minute infusion
Study Arms  ICMJE
  • Experimental: PF-04382923
    Intervention: Biological: RN6G
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 1, 2014)
10
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2012)
276
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date September 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Men and women between the ages of 60 and 90 years.
  • Diagnosis of a geographic atrophy (GA) secondary to dry Age-Related Macular Degeneration.
  • Best Corrected Visual Acuity (BCVA) of 20/80 or better in the study eye

Exclusion Criteria:

  • Evidence of ocular disease other than geographic atrophy (GA) secondary to dry Age-Related Macular Degeneration in the study eye.
  • History or diagnosis of exudative (wet) Age-Related Macular Degeneration, with subretinal or choroidal neovascular lesions in the study eye.
  • Presence of disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, central nervous, immune, or gastrointestinal system
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 60 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Germany,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT01577381
Other Study ID Numbers  ICMJE B1181003
2012-000823-42 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP