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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
  Purpose

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.


Condition Intervention Phase
Age-Related Maculopathy
Biological: RN6G
Biological: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: August 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
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

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.

  Eligibility

Ages Eligible for Study:   60 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577381

  Show 43 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01577381     History of Changes
Other Study ID Numbers: B1181003
Study First Received: April 11, 2012
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Phase 2
Advanced Dry Age-Related Macular Degeneration
Geographic Atrophy
RN6G

Additional relevant MeSH terms:
Atrophy
Geographic Atrophy
Macular Degeneration
Eye Diseases
Pathological Conditions, Anatomical
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on November 24, 2014