Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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6 October 2015 |
Main ID: |
EUCTR2012-000823-42-DE |
Date of registration:
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21/08/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A trial to investigate the efficacy and safety of treatment with RN6G in patients with age related macular degenerateion resulting in age-related loss of central vision.
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Scientific title:
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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 - B1181003 Clinical Study of RN6G (PF-04382923) |
Date of first enrolment:
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05/02/2013 |
Target sample size:
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276 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000823-42 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 4
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Phase:
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Countries of recruitment
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Australia
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Canada
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Germany
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Italy
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Spain
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Trials.gov Call Center
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Address:
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235 E 42nd Street
NY 10017
New York
United States |
Telephone:
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+18007181021 |
Email:
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ClinicalTrials.gov_Inquiries@pfizer.com |
Affiliation:
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Pfizer Inc |
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Name:
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Clinical Trials.gov Call Center
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Address:
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235 E 42nd Street
NY 10017
New York
United States |
Telephone:
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+18007181021 |
Email:
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ClinicalTrials.gov_Inquiries@pfizer.com |
Affiliation:
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Pfizer Inc |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Men and women between the ages of 60 and 90 years, inclusive.
2. Diagnosis of a well demarcated area of geographic atrophy (GA) secondary to dry AMD.
One eye (designated as the study eye) must have the following for AREDS AMD Levels Defined for Eyes):
• 3d: Geographic atrophy within grid but none at the center of the macula.
• 4a: Geographic atrophy in central subfield with at least questionable involvement of center of macula.
The other eye (designated as the fellow eye) can have Level 3 or 4a AMD. If both eyes have Level 3d or 4a AMD, then
the eye with the best BCVA would be considered the study eye; otherwise it should be considered the fellow eye. If
the ETDRS BCVA is the same in each eye, then the Investigator will designate the study and fellow eye.
A subject will be excluded from study if the fellow eye has Level 4b and has been or is currently being treated with anti
VEGF therapy.
The determination of AREDS AMD Levels will be made by a Central Reader.
3. GA total area between 2.0 and 17.5 mm2.
4. Best corrected visual acuity (BCVA) of =54 letter (20/80 (Snellen VA equivalent) or better in the study eye as
determined using an ETDRS chart.
5. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal
representative) has been informed of all pertinent aspects of the study.
6. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study
procedures. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 248
Exclusion criteria: Any disease or condition that might compromise the cardiovascular, hematological, renal, hepatic, pulmonary, endocrine, central nervous, immune, or gastrointestinal systems (unless deemed not clinically significant by the Investigator and Sponsor) such as, but not limited to:
a. Diagnosis or history of Alzheimer’s disease, dementia of any cause such as untreated thyroid disease or stroke or neuro degenerative disorders (eg, Parkinson’s disease, Lewy body disease, fronto temporal dementia, vascular dementia);
b. History or systemic signs of inflammatory bowel disease, multiple sclerosis, systemic lupus erythematosus;
c. History of cancer within the last 5 years (except for cutaneous basal cell or squamous cell cancer resolved by excision);
d. Presence of uncontrolled hypertension (uncontrolled hypertension is defined as a systolic blood pressure greater than 140 mm Hg or a diastolic blood pressure greater than 90 mm Hg, even with treatment). Subjects who have hypertension and are controlled on stable dosages of anti hypertensive medications can be included;
e. Poorly controlled Type 1 and Type 2 diabetes mellitus (HbA1c >9%). HbA1c must be obtained only for subjects with a known diagnosis of diabetes.
History or diagnosis of ocular disease other than advanced dry AMD or GA in the study eye that would confound the results of the study, such as diabetic retinopathy with microhemorrhage, uveitis (CTCAE Grade =2), or pseudovitelliform macular degeneration.
History or diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions in the study or fellow eye.
History of ocular infection, ocular inflammation or laser or cataract surgery within 3 months of Day 1.
History of ocular trauma or surgery (other than laser or cataract surgery) within 6 months of Day 1.
History of laser photocoagulation in the study eye.
Presence of ocular lens opacities preventing vision testing: cortical opacity greater than standard 3, posterior subcapsular opacity greater than standard 2, or a nuclear opacity greater than standard 3 (as measured on the AREDS clinical lens grading system).
History of optic amblyopia, glaucoma, optic nerve or other retinal disease or dysfunction (eg, disorders leading to or associated with retinal detachment, macular edema, atrophic retinal holes, retinal tears, retinal detachment, exudative retinal detachment, retinal toxicities due to medications, retinitis pigmentosa). Subjects with cobblestone or paving stone peripheral retinal degeneration are acceptable.
Subjects expected to need ocular surgery during the study.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Advanced, Dry, Age-Related Macular Degeneration including Geographic Atrophy MedDRA version: 15.0
Level: PT
Classification code 10064930
Term: Age-related macular degeneration
System Organ Class: 10015919 - Eye disorders
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Therapeutic area: Diseases [C] - Eye Diseases [C11]
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Intervention(s)
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Product Name: RN6G Product Code: PF-04382923 Pharmaceutical Form: Solution for injection INN or Proposed INN: N/A Current Sponsor code: PF-04382923 Other descriptive name: RN6G Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Solution for injection/infusion Route of administration of the placebo: Intravenous use
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Primary Outcome(s)
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Secondary Objective: • To examine retinal structural and functional deficits with ocular assessments for the study and the fellow eye. • To examine the safety, tolerability and immunogenicity of RN6G in subjects. • To characterize the population pharmacokinetic (PK) profile of RN6G. • To demonstrate the effect of RN6G on plasma Aß(1-x)(total), Aß(1-40) and Aß(1-42) concentrations.
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Main Objective: To determine the efficacy of RN6G in subjects with geographic atrophy in the study eye.
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Timepoint(s) of evaluation of this end point: The mean reduction in the rate of growth of GA area (in mm2) at 30 days post last dose administration (Day337)
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Primary end point(s): The mean reduction in the rate of growth of GA area (in mm2) at 30 days post last dose administration (Day 309) and at end of study with FAF.
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Secondary Outcome(s)
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Secondary end point(s): BCVA
• The mean BCVA letter number and line number after RN6G at 9, 12, 15 months and end of study compared to baseline and placebo.
• The mean percentage change from baseline in the correct number of letters after RN6G at 9, 12, 15 months and end of study.
• The mean percentage change from baseline in the correct number of lines after RN6G at 9, 12, 15 months and end of study.
Low Luminance (LL) BCVA
• The mean LL BCVA letter number and line number after RN6G at 9, 12, 15 months and end of study compared to baseline and placebo.
• The mean percentage change from baseline in the correct number of letters after RN6G at 9, 12, 15 months and end of study.
• The mean percentage change from baseline in the correct number of lines after RN6G at 9, 12, 15 months and end of study.
Contrast Sensitivity
• The mean change in Logmar units compared to baseline and placebo at 9, 12, 15 months and end of study.
• The percentage change from baseline in Logmar units at 9, 12, 15 months and end of study.
Reading
• The mean reading acuity and speed change from baseline at 9, 12, 15 months and end of study.
• The mean reading acuity and speed change from placebo at 9, 12, 15 months and end of study.
• The mean critical print size change from baseline and placebo at 9, 12, 15 months and end of study.
• The percentage change from baseline in reading acuity and speed at 9, 12, 15 months and end of study.
Safety
• Incidence, severity and causal relationship of treatment emergent AEs (TEAEs).
• Incidence of abnormal and clinically relevant safety laboratories including clinical chemistry, hematology and coagulation assessments.
• Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters.
• Incidence of anti-drug-antibodies.
Pharmacokinetics
• Plasma RN6G concentrations at specified time points and population PK parameter estimates for AUCt, Cmax, Cmin, CL at steady state, and accumulation ratio on AUCt between the first and last (11th) doses.
Pharmacodynamics
• Change from baseline (absolute and %) of plasma Aß(1-x) (total), Aß(1-40) and Aß(1-42) concentrations.
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Timepoint(s) of evaluation of this end point: 1) The mean BCVA letter number and line number after RN6G at 9, 12, and 15 months compared to placebo.
2) The mean percentage change from baseline in the correct number of letters after RN6G at 9, 12 and 15 months.
3) The mean percentage change from baseline in the correct number of lines after RN6G at 9, 12, and 15 months
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Secondary ID(s)
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102691
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B1181003
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Source(s) of Monetary Support
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Pfizer Inc., 235 East 42nd Street, New York, NY 10017
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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