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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01577381
First received: April 11, 2012
Last updated: March 6, 2014
Last verified: March 2014

April 11, 2012
March 6, 2014
August 2012
October 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01577381 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Incidence of anti-drug-antibodies. [ Time Frame: Days 28, 57, 85, 169, 253, 337 and 449 ] [ Designated as safety issue: Yes ]
  • Plasma RN6G concentrations at specified time points and population PK parameter estimates for AUCτ, Cmax, Cmin, CL at steady state, and accumulation ratio on AUCτ between the first and last (11th) doses. [ Time Frame: Days 1, 28, 57, 85, 169, 253, 281, 309, 337 and 449 ] [ Designated as safety issue: No ]
  • Change from baseline (absolute and %) of plasma Aβ(1-x) (total), Aβ(1-40) and Aβ(1-42) concentrations. [ Time Frame: Days 1, 28, 57, 85, 169, 253, 281, 309, 337 and 449 ] [ Designated as safety issue: No ]
  • 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: Days 28, 57, 85, 169, 253, 337 and 449 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Incidence of anti-drug-antibodies. [ Time Frame: Days 28, 57, 85, 169, 253, 337 and 449 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy, Safety And Tolerability Study Of RN6G In Subjects With Geographic Atrophy Secondary to Age-related Macular Degeneration
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Age-Related Maculopathy
  • 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
  • Experimental: PF-04382923
    Intervention: Biological: RN6G
  • Placebo Comparator: Placebo
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
10
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
60 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01577381
B1181003
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2014

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