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History of Changes for Study: NCT01577381
Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration
Latest version (submitted February 16, 2016) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 11, 2012 None (earliest Version on record)
2 May 29, 2012 Outcome Measures and Study Status
3 June 25, 2012 Study Status
4 July 23, 2012 Study Status
5 August 29, 2012 Recruitment Status, Study Status and Contacts/Locations
6 September 26, 2012 Study Status and Contacts/Locations
7 October 31, 2012 Study Status and Contacts/Locations
8 January 16, 2013 Recruitment Status, Study Status and Contacts/Locations
9 February 18, 2013 Recruitment Status, Study Status and Contacts/Locations
10 March 27, 2013 Study Status, Outcome Measures, Contacts/Locations and Conditions
11 May 6, 2013 Contacts/Locations and Study Status
12 June 5, 2013 Study Status and Contacts/Locations
13 July 4, 2013 Study Status and Contacts/Locations
14 August 22, 2013 Study Status and Contacts/Locations
15 September 23, 2013 Study Status
16 October 24, 2013 Recruitment Status, Study Status, Contacts/Locations and Study Design
17 November 24, 2013 Study Status and Contacts/Locations
18 December 29, 2013 Study Status and Study Design
19 January 29, 2014 Study Status
20 March 1, 2014 Recruitment Status, Study Status, Study Design and Study Description
21 March 6, 2014 Study Status
22 November 6, 2015 Contacts/Locations, Study Status, Study Identification and Study Design
23 February 16, 2016 Outcome Measures, Study Status, More Information, Adverse Events, Baseline Characteristics and Participant Flow
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Study NCT01577381
Submitted Date:  April 11, 2012 (v1)

Open or close this module Study Identification
Unique Protocol ID: B1181003
Brief Title: Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration
Official Title: 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
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2012
Overall Status: Not yet recruiting
Study Start: June 2012
Primary Completion: December 2012 [Anticipated]
Study Completion: June 2014 [Anticipated]
First Submitted: April 11, 2012
First Submitted that
Met QC Criteria:
April 11, 2012
First Posted: April 13, 2012 [Estimate]
Last Update Submitted that
Met QC Criteria:
April 11, 2012
Last Update Posted: April 13, 2012 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Pfizer
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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:
Open or close this module Conditions
Conditions: Age-Related Maculopathy
Age-Related Maculopathies
Eye Diseases
Retinal Degeneration
Macular Degeneration
Keywords: Phase 2
Advanced Dry Age-Related Macular Degeneration
Geographic Atrophy
RN6G
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 2
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation: Randomized
Enrollment: 276 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: PF-04382923 Biological: RN6G
Intravenous, 11 doses, 30 minute infusion, dose ranging from 2.5 mg/kg up to a maximum of 15 mg/kg
Placebo Comparator: Placebo Biological: Placebo
Intravenous, 11 doses, 30 minute infusion
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The mean reduction in the rate of growth of Geographic Atrophy area (in mm2) at 30 days post last dose administration (Day 309) and at end of study measured with Fundus Autofluorescence.
[ Time Frame: Screening, Day 85, Day 197, Day 309, Day 393 and Day 449 ]

Secondary Outcome Measures:
1. The mean Best Corrected Visual Acuity (BCVA) letter number and line number after RN6G at 9, 12, 15 months and end of study compared to baseline and placebo.
[ Time Frame: Screening, Day 85, Day 197, Day 309, Day 393 and Day 449 ]

2. The mean percentage change from baseline in the correct number of letters after RN6G at 9, 12, 15 months and end of study using the measure of Best Corrected Visual Acuity (BCVA).
[ Time Frame: Screening, Day 85, Day 197, Day 309, Day 393 and Day 449 ]

3. The mean percentage change from baseline in the correct number of lines after RN6G at 9, 12, 15 months and end of study using the measure of Best Corrected Visual Acuity (BCVA).
[ Time Frame: Screening, Day 85, Day 197, Day 309, Day 393 and Day 449 ]

4. The mean Low Luminance Best Corrected Visual Acuity (LL-BCVA) letter number and line number after RN6G at 9, 12, 15 months and end of study compared to baseline and placebo.
[ Time Frame: Screening, Day 85, Day 197, Day 309, Day 393 and Day 449 ]

5. The mean percentage change from baseline in the correct number of letters after RN6G at 9, 12, 15 months and end of study using the measure of Low Luminance Best Corrected Visual Acuity (LL-BCVA).
[ Time Frame: Screening, Day 85, Day 197, Day 309, Day 393 and Day 449 ]

6. The mean percentage change from baseline in the correct number of lines after RN6G at 9, 12, 15 months and end of study using the measure of Low Luminance Best Corrected Visual Acuity (LL-BCVA).
[ Time Frame: Screening, Day 85, Day 197, Day 309, Day 393 and Day 449 ]

7. The mean change in Logmar units compared to baseline and placebo at 9, 12, 15 months and end of study using the measure of Contrast Sensitivity.
[ Time Frame: Screening, Day 85, Day 197, Day 309, Day 393 and Day 449 ]

8. The percentage change from baseline in Logmar units at 9, 12, 15 months and end of study using the measure of Contrast Sensitivity.
[ Time Frame: Screening, Day 85, Day 197, Day 309, Day 393 and Day 449 ]

9. The mean reading acuity and speed change from baseline at 9, 12, 15 months and end of study.
[ Time Frame: Screening, Day 85, Day 197, Day 309, Day 393 and Day 449 ]

10. The mean reading acuity and speed change from placebo at 9, 12, 15 months and end of study.
[ Time Frame: Screening, Day 85, Day 197, Day 309, Day 393 and Day 449 ]

11. The mean critical print size change from baseline and placebo at 9, 12, 15 months and end of study.
[ Time Frame: Screening, Day 85, Day 197, Day 309, Day 393 and Day 449 ]

12. The percentage change from baseline in reading acuity and speed at 9, 12, 15 months and end of study.
[ Time Frame: Screening, Day 85, Day 197, Day 309, Day 393 and Day 449 ]

13. The mean overall macular sensitivity of all points and change from baseline and placebo at 9, 12, 15 months and end of study using microperimetry.
[ Time Frame: Screening, Day 85, Day 197, Day 309, Day 393 and Day 449 ]

14. The mean macular sensitivity of responding points and change from baseline and placebo at 9, 12, 15 months and end of study using microperimetry.
[ Time Frame: Screening, Day 85, Day 197, Day 309, Day 393 and Day 449 ]

15. The mean number of scotomatous points (sensitivity <0 dB) and change from baseline and placebo at 9, 12, 15 months and end of study using microperimetry.
[ Time Frame: Screening, Day 85, Day 197, Day 309, Day 393 and Day 449 ]

16. Incidence, severity and causal relationship of treatment emergent Adverse Events (TEAEs).
[ Time Frame: Days 1, 28, 57, 85, 113, 141, 169, 190, 225, 253, 281, 309, 337, 365, 393, 421 and 449 ]

17. Incidence of abnormal and clinically relevant safety laboratories including clinical chemistry, hematology and coagulation assessments.
[ Time Frame: Days 28, 85, 169, 281, 365 and 449 ]

18. Abnormal and clinically relevant changes in vital signs, Blood Pressure, and Electrocardiogram parameters.
[ Time Frame: Days 1, 28, 57, 85, 113, 141, 169, 225, 253, 281, 309, 337, 365, 393 and 449 ]

19. Incidence of anti-drug-antibodies.
[ Time Frame: Days 28, 57, 85, 169, 253, 337 and 449 ]

20. Measurement of the retinal anatomical structure, including the retinal surface, intraretinal alterations and subretinal morphology and changes from baseline after treatment.
[ Time Frame: Screening, Day 85, Day 197, Day 309, Day 393 and Day 449 ]

21. The frequency of specific Fundus Autofluorescence patterns in Age-related Macular Degeneration at baseline and changes in these patterns and, lipofuscin accumulation after treatment.
[ Time Frame: Screening, Day 85, Day 197, Day 309, Day 393 and Day 449 ]

Open or close this module Eligibility
Minimum Age: 60 Years
Maximum Age: 90 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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
Open or close this module Contacts/Locations
Central Contact Person: Pfizer CT.gov Call Center
Telephone: 1-800-718-1021
Study Officials: Pfizer CT.gov Call Center
Study Director
Pfizer
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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