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

NCT00538538 | Withdrawn Phase 1

• 1 other identifier: HIC 2007-073
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Hemorrhage; Macular Degeneration

Keywords

Macular Degeneration; AMD; Hemorrhage; Wet AMD

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (1)

• Mean change in visual acuity, angiographic area, retinal thickness by optical coherence tomography, mean number of retreatments required by 12 months.

  12 months

Study Arms (2)

A

ACTIVE COMPARATOR

Does not receive Gas bubble

Drug: vitrectomy with subretinal lucentis

B

ACTIVE COMPARATOR

Does receive gas bubble

Drug: vitrectomy with subretinal lucentis

Interventions

vitrectomy with subretinal lucentis DRUG

A gas bubble will be placed in the eye after the gel has been removed.

B

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Corewell Health East: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Retinal Hemorrhage; Macular Degeneration; Hemorrhage

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Eye Hemorrhage; Eye Diseases; Retinal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Tarek Hassan, MD

  Associated Retinal Consultants/William Beaumont Hosp.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 1, 2007
• First Posted: October 2, 2007
• Study Start: September 1, 2007
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 8, 2016

Record last verified: 2016-08

Locations

US (1)