The Effect of Intravitreal Avastin on the Retina Measured by Electroretinogram

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the scotopic and photopic ERG responses before and after one month of intravitreal avastin injection in patients with choroidal neovascularization.

A positive finding that will reveal a toxic effect of intravitreal avastin injection on any component of the retina will have a significant important clinical impact regarding the decision whether the benefit of avastin treatment for CNV will prevail over toxic effect.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effectiveness of Intravitreal Avastin Injection for CRVO

NCT01678248

Central Retinal Vein Occlusion

UNKNOWN

Intravitreal Bevacizumab for Proliferative Diabetic Retinopathy

NCT00423059

Diabetic Retinopathy

COMPLETED NA

Intravitreal Bevacizumab for Choridal Neovascularization Secondary to Age-Related Macular Degeneration

NCT00556348

Age Related Macular Degeneration

COMPLETED PHASE4

Bevacizumab Effect on Blood Velocity

NCT01298440

Choroidal Neovascularization

COMPLETED

Multifocal Electrophysiologic Findings After Intravitreal Bevacizumab(Avastin)Treatment

NCT00417833

Diabetic Proliferative Retinopathy Vascular Vein Oclussion Choroidal Neovascularization

TERMINATED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The study will include 20 patients who are diagnosed with CNV and were submitted for intravitreal injection of avastin. Patients with uncontrolled glaucoma, any ocular operation two months prior to the injection, ocular inflammatory disease, systemic hypertension treated with more than one medication, myocardial infarct, congestive heart disease will not be included in the study. After the patient will approve to participate in the study and will fall in with the inclusion and exclusion criteria, the patient will sign a written consent statement (enclosed).

Medical history and ophthalmic examination will be written in the study file. The patients will undergo the full-field ERG test using the ISCEV Protocol. Since the ERG is a non invasive test the patient will be admitted on the same day for intravitreal avastin in the designated eye. After one month the patient will undergo identical ERG protocol in addition to the standard follow-up examinations protocol for intravitreal avastin injection (1 day, 1 week, 1 month). The other eye will serve as control group.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Macular Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ELECTRORETINOGRAM

Bevacizumab 1.25 mg/0.05 ml unilaterally into the vitreous cavity as part of the standard management for choroidal neovascular AMD. ERG responses form both eyes will be measured at baseline and 1 month after intravitreal injection

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Patients who were diagnosed with CNV caused by ARMD
2. ERG can be performed in both eyes

Exclusion Criteria

1. Treatment within 7 days with VERTOPROFIN
2. Treatment within one month with laser photocoagulation
3. Ocular surgery for AMD (besides laser).
4. Participation in other medical study
5. Sub-fovea RPE atrophy in the study eye.
6. CNV with ocular histoplasmosis, trauma, pathological myopia.
7. Uveitis or history of uveitis.
8. Retinal pigment epithelium tear in the fovea of the injected eye.
9. Vitreous hemorrhage
10. Conjunctivitis, keratitis, scleritis, endophthalmitis.
11. Intraocular surgery (including cataract) within two months
12. Uncontrolled glaucoma (IOP≥30 mmHg under glaucoma medications)
13. Hypertension treated with two or more medication
14. History of myocardial infarct
15. History of myocardial insufficiency -

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No