Subretinal Lucentis for Hemorrhagic Age-Related Macular Degeneration (AMD) - Full Text View

Sponsored by:	William Beaumont Hospitals
Information provided by:	William Beaumont Hospitals
ClinicalTrials.gov Identifier:	NCT00538538

Purpose

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.

Condition	Intervention	Phase
Retinal Hemorrhage Macular Degeneration	Procedure: vitrectomy	Phase I

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Gas Macular Degeneration

Drug Information available for: Ranibizumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Use of Subretinal Ranibizumab (Lucentis) in the Management of Submacular Hemorrhage in Neovascular Age-Related Macular Degeneration (AMD)

Further study details as provided by William Beaumont Hospitals:

Primary Outcome Measures:

To investigate the safety and tolerability of vitrectomy combined with a single dose of subretinal Ranibizumab (Lucentis - 0.5 mg) in patients with submacular hemorrhage and choroidal neovascular membranes secondary to AMD. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean change in visual acuity, angiographic area, retinal thickness by optical coherence tomography, mean number of retreatments required by 12 months. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	September 2007
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Does not receive Gas bubble	Procedure: vitrectomy These patients will have a vitrectomy where the gel is removed but will not receive the gas bubble.
B: Active Comparator Does receive gas bubble	Procedure: vitrectomy A gas bubble will be placed in the eye after the gel has been removed.

Detailed Description:

Subjects will be followed for a period of 12 months. Based on photographs and other testing procedures, if it is deemed in the subject's best interest, the subject may receive monthly injections of Lucentis to help treat the AMD.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Age over 50 years
Vision 20/200 or worse
AMD with submacular hemorrhage
Hemorrhage more than 25% of the lesion
Fibrosis or scar not more than 25% of the entire lesion
Hemorrhage less than 3 months old
Vision loss occuring within 3 months

Exclusion Criteria:

Pregnancy
Participating in any other clinical trial
Prior treatment for AMD
Other medical conditions causing compromised vision
Intraocular eye surgery within the previous 12 months
Inability to obtain necessary eye photographs
Systemic use of anti-VEGF agents
Allergy to fluorescein dye
Unable to complete all study visits
Glaucoma filtering surgery
Use of 2 or more treatments for glaucoma
Lack of lens in the eye or absence of a posterior capsule

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538538

Locations

United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073

Sponsors and Collaborators

William Beaumont Hospitals

Investigators

Principal Investigator:

Tarek Hassan, MD

Associated Retinal Consultants/William Beaumont Hosp.

More Information

Responsible Party:	Associated Retinal Consultants, P.C. ( Tarek Hassan, M.D. )
Study ID Numbers:	4149s
Study First Received:	October 1, 2007
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00538538
Health Authority:	United States: Food and Drug Administration

Keywords provided by William Beaumont Hospitals:

Macular Degeneration
AMD
Hemorrhage
Wet AMD

Study placed in the following topic categories:

Eye Diseases
Retinal Hemorrhage
Retinal Degeneration
Macular Degeneration

Hemorrhage
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

Pathologic Processes
Eye Hemorrhage

ClinicalTrials.gov processed this record on January 16, 2009