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

This study has been withdrawn prior to enrollment.
(This condition can now be managed in the office with an injection of Lucentis.)
Sponsor:
Information provided by:
William Beaumont Hospitals
ClinicalTrials.gov Identifier:
NCT00538538
First received: October 1, 2007
Last updated: August 19, 2009
Last verified: August 2009
History of Changes
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of Subretinal Ranibizumab (Lucentis) in the Management of Submacular Hemorrhage in Neovascular Age-Related Macular Degeneration (AMD)

Resource links provided by NLM:

Drug Information available for: Ranibizumab
U.S. FDA Resources

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
Active Comparator: A
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.
Active Comparator: B
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

No publications provided

Responsible Party: Tarek Hassan, M.D., Associated Retinal Consultants, P.C.
ClinicalTrials.gov Identifier: NCT00538538     History of Changes
Other Study ID Numbers: HIC 2007-073
Study First Received: October 1, 2007
Last Updated: August 19, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by William Beaumont Hospitals:
Macular Degeneration
AMD
Hemorrhage
Wet AMD

Additional relevant MeSH terms:
Hemorrhage
Macular Degeneration
Retinal Hemorrhage
Pathologic Processes
 Retinal Degeneration
Retinal Diseases
Eye Diseases
Eye Hemorrhage

ClinicalTrials.gov processed this record on May 16, 2013