Changes in Retinal Function After Intravitreal Ranibizumab for Age-related Macular Degeneration

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-02-28

Brief Summary

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Age-related macular degeneration, a leading cause of blindness, is caused by an abnormal growth of the vessels beneath the retina. Ranibizumab (Lucentis) is a new drug that inhibits the growth of new vessels and has recently been approved by FDA for treating this condition. This study is carried out to evaluate the changes in retinal function after an injection of ranibizumab.

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Detailed Description

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The functional changes of the retina can be recorded by an electroretinography (ERG).

Conditions

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Age-related Macular Degeneration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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ranibizumab

A single dose of 0.5 mg ranibizumab injected intravitreally.

Intervention Type DRUG

Other Intervention Names

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Lucentis

Eligibility Criteria

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Inclusion Criteria

* Age 45 years and above
* Clinical diagnosis of wet AMD
* First injection of ranibizumab protocol
* Best corrected visual acuity 20/32 - 20/320
* Consent form obtained

Exclusion Criteria

* Previously treated wet AMD patients
* Patients with other ocular diseases which can cause abnormal ERG such as glaucoma, uveitis or retinitis pigmentosa, etc.
* Pregnancy
* History of seizure

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No