Clinical trial NCT00538538: Subretinal Lucentis for Hemorrhagic Age-related Macular Degeneration (AMD)
Official title: Use of Subretinal Ranibizumab (Lucentis) in the Management of Submacular Hemorrhage in Neovascular Age-Related Macular Degeneration (AMD)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Retinal Hemorrhage
Macular Degeneration
Keywords: Macular Degeneration
AMD
Hemorrhage
Wet AMD
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2007-10-02
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: 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.
timeFrame: 12 months
Secondary outcomes:
measure: Mean change in visual acuity, angiographic area, retinal thickness by optical coherence tomography, mean number of retreatments required by 12 months.
timeFrame: 12 months
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: Associated Retinal Consultants/William Beaumont Hosp.
name: Tarek Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References: