Safety and Efficacy Study of rAAV.sFlt-1 in Patients With Exudative Age-Related Macular Degeneration

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2017-08-31

Brief Summary

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The study will involve approximately 40 subjects aged 55 or above who have exudative age-related macular degeneration (wet AMD). Patients will be randomized to receive one of two doses of rAAV.sFlt-1 or assigned to the control group.

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Detailed Description

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A new treatment for exudative age-related macular degeneration (wet AMD) is being investigated. The purpose of this Phase I/II clinical research study is to examine the baseline safety and efficacy of an experimental study drug to treat a complication of the disease which leads to vision loss. The name of the study drug is rAAV.sFlt-1.

This experimental study uses a non-pathogenic virus to express a therapeutic protein within the eye. The therapeutic diminishes the growth of abnormal blood vessels under the retina. The duration of effect is thought to be long-term (years) following a single administration.

The clinical research study will look at the baseline safety and efficacy of a single injection of rAAV.sFlt-1 injected directly into the eye.

Approximately forty (40) subjects will participate in Australia. The primary endpoint of the study is at one month, with extended follow up for 3 years.

Conditions

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Macular Degeneration Age-related Maculopathies Age-related Maculopathy Maculopathies,Age-related Maculopathy,Age-related Retinal Degeneration Retinal Neovascularization Eye Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Low Dose rAAV.sFlt-1

Group Type EXPERIMENTAL

rAAV.sFlt-1

Intervention Type BIOLOGICAL

1 x 10\^10 vector genomes (vg) rAAV.sFlt-1, delivered by subretinal injection

High Dose rAAV.sFlt-1

Group Type EXPERIMENTAL

rAAV.sFlt-1

Intervention Type BIOLOGICAL

1 x 10\^11 vector genomes (vg) rAAV.sFlt-1, delivered by subretinal injection

Control - ranibizumab only

Group Type ACTIVE_COMPARATOR

Control (ranibizumab alone)

Intervention Type OTHER

Patients will not receive rAAV.sFlt-1, but will be eligible for retreatment with ranibizumab (Lucentis).

Interventions

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rAAV.sFlt-1

1 x 10\^10 vector genomes (vg) rAAV.sFlt-1, delivered by subretinal injection

Intervention Type BIOLOGICAL

rAAV.sFlt-1

1 x 10\^11 vector genomes (vg) rAAV.sFlt-1, delivered by subretinal injection

Intervention Type BIOLOGICAL

Control (ranibizumab alone)

Patients will not receive rAAV.sFlt-1, but will be eligible for retreatment with ranibizumab (Lucentis).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age greater than or equal to 55 years;
* Subfoveal CNV secondary to AMD and with best corrected visual acuity of 3/60 - 6/9 with 6/60 or better in the other eye;
* Fluorescein angiogram of the study eye must show evidence of a leaking subfoveal choroidal neovascular lesion, or CNV currently under active management with anti-VEGF therapy;
* Must be a candidate for anti-VEGF intravitreal injections;
* No previous retinal treatment of photodynamic therapy or laser;
* Able to provide informed consent;
* Able to comply with protocol requirements, including follow-up visits.

Exclusion Criteria

* Liver enzymes \> 2 X upper limit of normal;
* Any prior treatment for AMD in the study / control eye, excluding anti-VEGF injections;
* Extensive sub-foveal scarring, extensive geographic atrophy, or thick subretinal blood in the study eye as determined by the investigator;
* Significant retinal disease other than sub-foveal CNV AMD;

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No