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Subretinal Lucentis for Hemorrhagic Age-related Macular Degeneration (AMD)

NCT00538538 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-08-08

No results posted yet for this study

Summary

Visual outcomes of the eye with large subretinal hemorrhages (bleeding under the retina) due to Age-Related Macular Degeneration (AMD) are poor. The Submacular Surgery Trial (SST) showed that no statistically significant improvement in vision resulted from surgical removal of the layer of abnormal blood vessels causing the bleeding. However, placement of a gas bubble into the gel of the eye along with removal of the blood has shown some success. However, this does not treat the underlying condition of the AMD.

Intravitreal injections (into the gel of the eye) of a drug called Lucentis has been shown to be highly effective in the treatment of AMD, yet its penetration through areas of thick blood caused by subretinal hemorrhage is not known.

This study is proposing to treat the AMD causing the subretinal hemorrhage with a vitrectomy (surgery involving removing the gel inside the eye, and membrane layers of the eye) followed by Lucentis placed between the layers of the retina and then with or without a gas bubble.

In order to determine if the the subretinal Lucentis alone is beneficial, 5 of the 10 patients enrolled will get a gas bubble and the other 5 will not.

Conditions

  • Retinal Hemorrhage
  • Macular Degeneration

Interventions

DRUG

vitrectomy with subretinal lucentis

A gas bubble will be placed in the eye after the gel has been removed.

DRUG

vitrectomy with subretinal lucentis

These patients will have a vitrectomy where the gel is removed but will not receive the gas bubble.

Sponsors & Collaborators

  • William Beaumont Hospitals

    lead OTHER

Principal Investigators

  • Tarek Hassan, MD · Associated Retinal Consultants/William Beaumont Hosp.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00538538 on ClinicalTrials.gov