Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

RN6G

Placebo

About this trial

This is an interventional prevention trial for Age-Related Maculopathy focused on measuring Phase 1, Dry Age Related Macular Degeneration, RN6G

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Be of non-childbearing potential.
Diagnosis of dry AMD as defined by the Age-Related Eye Disease Study (AREDS, 2005), including uni- or multi-focal GA, without foveal involvement.
BCVA of 20/320 or better in the worst eye.

Exclusion Criteria:

Diagnosis of exudative (wet) AMD, with subretinal or choroidal neovascular lesions.
Diagnosis or history of Alzheimer's disease, dementia or neurodegenerative disorders.
Diagnosis or recent history of clinically significant cerebrovascular disease.
Uncontrolled hypertension.
Uncontrolled Type 1 or Type 2 diabetes mellitus.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Incidence and Severity of Ocular Adverse Events (AEs)

AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Ocular AE was identified by spontaneous report or ocular examination: early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA); low-luminance BCVA; pupillary light response, extra-ocular muscle movements, external examination of the eyelids and eyelashes, slit-lamp biomicroscopic examination (SLE) of all components of the anterior and posterior segments, intra-ocular pressure (IOP), and dilated ocular fundus examination of the vitreous and retina. AE was assessed according to severity; mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). Total number of participants with ocular (related to eye) AEs and severity was reported.

Incidence and Severity of Systemic Adverse Events (AEs)

AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Systemic AEs was identified by spontaneous report or physical and neurological examinations changes in vital signs, clinical laboratory abnormalities, 12-lead electrocardiograms (ECG), brain magnetic resonance imaging (MRI). AE was assessed according to severity; mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). Total number of participants with systemic (all AEs including eye-related) AEs and severity was reported.

Secondary Outcome Measures

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of RN6G

AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Participants who received RN6G were reported.

Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] of RN6G

AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t). Participants who received RN6G were reported.

Maximum Observed Plasma Concentration (Cmax) of RN6G

Participants who received RN6G were reported.

Time to Reach Maximum Observed Plasma Concentration (Tmax) of RN6G

Participants who received RN6G were reported.

Volume of Distribution (Vd) of RN6G

Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Participants who received RN6G were reported and volume was measured as volume/kg of body weight.

Clearance (CL) of RN6G

CL is a quantitative measure of the rate at which a drug substance is removed from the body. Participants who received RN6G were reported and clearance was measured as mL/hr/kg of body weight.

Mean Residence Time (MRT) of RN6G

MRT was calculated as area under the moment curve from time 0 to extrapolated infinite time (AUMC[0 to inf])/area under the concentration effect curve from time 0 to extrapolated infinite time (AUC[0 to inf]). AUMC (0 to inf)= area under the moment curve from 0 to time t (AUMC 0-t) + [(Ct*tlast )/lamdaz ] + [Ct/(lamdaz )^2 ] where Ct= last measurable concentration, tlast= last measurable time, lamdaz= apparent terminal elimination rate constant. Participants who received RN6G were reported.

Plasma Terminal Half-life (t1/2) of RN6G

Plasma terminal half-life is the time measured for the plasma concentration to decrease by one half. Participants who received RN6G were reported.

Maximum Observed Plasma Concentration (Cmax) of Amyloid (A) Beta(1-X)

Time to Reach Maximum Observed Plasma Concentration (Tmax) of Amyloid (A) Beta(1-X)

Area Under the Curve From Time Zero to Day 165 [AUC (0-165d)] of Amyloid (A) Beta(1-X)

AUC (0-165d)= Area under the plasma concentration versus time curve from time zero (pre-dose) to Day 165.

Number of Participants With Anti-Drug Anti-body

Participants tested positive for anti-drug anti-body on at least one or more occasions were reported.

Full Information

NCT ID

NCT00877032

First Posted

April 6, 2009

Last Updated

March 20, 2015

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00877032

Brief Title

Safety And Tolerability Study Of RN6G In Patients With Dry, Age-Related Macular Degeneration

Official Title

A Phase I, Double-masked, Placebo-controlled Study Evaluating The Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, And Immunogenicity Of Single Escalating Doses Of Rn6g In Patients With Dry, Age-related Macular Degeneration (Amd)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

July 2011 (Actual)

Study Completion Date

July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

The purpose of this study is to determine the safety and tolerability of RN6G in patients with dry, age-related macular degeneration.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-Related Maculopathy, Age-Related Maculopathies, Eye Diseases, Retinal Degeneration, Macular Degeneration

Keywords

Phase 1, Dry Age Related Macular Degeneration, RN6G

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

RN6G

Intervention Description

intravenous, single dose, dose ranging from 0.3mg/kg up to a maximum of 40 mg/kg.

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

intravenous, single dose with experimental dose.

Primary Outcome Measure Information:

Title

Incidence and Severity of Ocular Adverse Events (AEs)

Description

AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Ocular AE was identified by spontaneous report or ocular examination: early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA); low-luminance BCVA; pupillary light response, extra-ocular muscle movements, external examination of the eyelids and eyelashes, slit-lamp biomicroscopic examination (SLE) of all components of the anterior and posterior segments, intra-ocular pressure (IOP), and dilated ocular fundus examination of the vitreous and retina. AE was assessed according to severity; mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). Total number of participants with ocular (related to eye) AEs and severity was reported.

Time Frame

Baseline up to Day 168

Title

Incidence and Severity of Systemic Adverse Events (AEs)

Description

AE: untoward medical occurrence in participant who received study drug without regard to causal relationship. Systemic AEs was identified by spontaneous report or physical and neurological examinations changes in vital signs, clinical laboratory abnormalities, 12-lead electrocardiograms (ECG), brain magnetic resonance imaging (MRI). AE was assessed according to severity; mild (did not interfere with participant's usual function), moderate (interfered to some extent with participant's usual function) and severe (interfered significantly with participant's usual function). Total number of participants with systemic (all AEs including eye-related) AEs and severity was reported.

Time Frame

Baseline up to Day 168

Secondary Outcome Measure Information:

Title

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - Inf)] of RN6G

Description

AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf). Participants who received RN6G were reported.

Time Frame