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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00538538
Recruitment Status : Withdrawn (This condition can now be managed in the office with an injection of Lucentis.)
First Posted : October 2, 2007
Last Update Posted : August 8, 2016
Information provided by:
William Beaumont Hospitals

Brief 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.

Condition or disease Intervention/treatment Phase
Retinal Hemorrhage Macular Degeneration Drug: vitrectomy with subretinal lucentis Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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)
Study Start Date : September 2007
Estimated Primary Completion Date : October 2008
Estimated Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Active Comparator: A
Does not receive Gas bubble
Drug: vitrectomy with subretinal lucentis
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
Drug: vitrectomy with subretinal lucentis
A gas bubble will be placed in the eye after the gel has been removed.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00538538

United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Sponsors and Collaborators
William Beaumont Hospitals
Principal Investigator: Tarek Hassan, MD Associated Retinal Consultants/William Beaumont Hosp.

Responsible Party: Tarek Hassan, M.D., Associated Retinal Consultants, P.C. Identifier: NCT00538538     History of Changes
Other Study ID Numbers: HIC 2007-073
First Posted: October 2, 2007    Key Record Dates
Last Update Posted: August 8, 2016
Last Verified: August 2016

Keywords provided by William Beaumont Hospitals:
Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Retinal Hemorrhage
Pathologic Processes
Retinal Degeneration
Retinal Diseases
Eye Diseases
Eye Hemorrhage
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents