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

Macular Degeneration Clinical Trial

Official title:

Use of Subretinal Ranibizumab (Lucentis) in the Management of Submacular Hemorrhage in Neovascular Age-Related Macular Degeneration (AMD)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00538538
• Other study ID #: HIC 2007-073
• Status: Withdrawn
• Phase: Phase 1
• First received: October 1, 2007
• Last updated: August 4, 2016
• Start date: September 2007
• Est. completion date: October 2008

Study information

• Verified date: August 2016
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemorrhage
• Macular Degeneration
• Retinal Hemorrhage

Intervention

Drug:
• vitrectomy with subretinal lucentis
A gas bubble will be placed in the eye after the gel has been removed.
• vitrectomy with subretinal lucentis
These patients will have a vitrectomy where the gel is removed but will not receive the gas bubble.

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
William Beaumont Hospitals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		12 months	No
Secondary	Mean change in visual acuity, angiographic area, retinal thickness by optical coherence tomography, mean number of retreatments required by 12 months.		12 months	No