Subretinal Lucentis for Hemorrhagic Age-related Macular D... | NCT00538538

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

NCT00538538

Sponsor

Corewell Health East

Status

Withdrawn

Last Update Posted

Aug 8, 2016Estimated

Enrollment

0Actual

Phase

Phase 1

Conditions

Retinal Hemorrhage
Macular Degeneration

Interventions

vitrectomy with subretinal lucentis
vitrectomy with subretinal lucentis

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2016

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

This condition can now be managed in the office with an injection of Lucentis.

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Oct 2008Estimated

Completion Date

Oct 2008Estimated

First Submitted Date

Oct 1, 2007

First Submission Date that Met QC Criteria

Oct 1, 2007

First Posted Date

Oct 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 4, 2016

Last Update Posted Date

Aug 8, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
vitrectomy with subretinal lucentis	Drug	A gas bubble will be placed in the eye after the gel has been removed.	B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tarek Hassan, MD	Associated Retinal Consultants/William Beaumont Hosp.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
William Beaumont Hospital		Royal Oak	Michigan	48073	United States

Condition Browse Module

MeSH Terms

ID	Term
D012166	Retinal Hemorrhage
D008268	Macular Degeneration
D006470	Hemorrhage

Ancestor Terms

ID	Term
D005130	Eye Hemorrhage
D005128	Eye Diseases
D012164	Retinal Diseases
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014821	Vitrectomy

Ancestor Terms

ID	Term
D013508	Ophthalmologic Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided