A Study of the Safety, Tolerability, Pharmacokinetics, an... | NCT00973011

Studies
A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of FCFD4514S in Patients With Geographic Atrophy

NCT00973011

Sponsor

Genentech, Inc.

Status

Completed

Last Update Posted

Dec 13, 2022Actual

Enrollment

18Actual

Phase

Phase 1

Conditions

Geographic Atrophy

Interventions

FCFD4514S

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2009

Primary Completion Date

Jul 2010Actual

Completion Date

Jul 2010Actual

First Submitted Date

Sep 8, 2009

First Submission Date that Met QC Criteria

Sep 8, 2009

First Posted Date

Sep 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 9, 2022

Last Update Posted Date

Dec 13, 2022Actual

Description Module

Brief Summary

The Phase Ia, open-label, multicenter study will consist of a single-dose, dose-escalation study of the safety, tolerability, pharmacokinetics, and immunogenicity of an intravitreal (ITV) injection of FCFD4514S in patients with Geographic Atrophy (GA).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

18Actual

Label	Type	Description	Intervention Names
A	Experimental		Drug: FCFD4514S

Name	Type	Description	Arm Group Labels	Other Names
FCFD4514S	Drug	Intravitreal escalating dose	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability of the study drug		Through study completion or early study discontinuation

Secondary Outcomes

Measure	Description	Time Frame
PK parameters of study drug (total exposure, maximum observed serum concentration, and time of maximum observed serum concentration)		Through study completion or early study discontinuation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Ability and willingness to undertake all scheduled visits and assessments
Agreement to use an effective form of contraception for the duration of the study
Geographic atrophy (GA) at least 0.75 disc areas in the absence of choroidal neovascularization (CNV)

Exclusion Criteria:

Treatment for active systemic infection
Predisposition or history of increased risk for infection
Active malignancy
History of medical conditions, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use an investigational drug or that might affect interpretation of the results of the study or that renders the patient at high risk for treatment complications
GA in either eye due to non-AMD causes
Active or history of ocular and intraocular conditions in the study eye (except GA)
History of vitreoretinal surgery or laser photocoagulation in the study eye
Prior treatment for AMD (except vitamins and minerals)
History of intravitreal (ITV) drug delivery
Intraocular surgery (including cataract surgery) in the study eye within 3 months preceding Day 0
Previous participation in any studies of investigational drugs within 1 month preceding Day 0 (excluding vitamins and minerals)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D008268	Macular Degeneration
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases