Retinal HemorrhagePhase 1NCT00538538
Subretinal Lucentis for Hemorrhagic Age-related Macular Degeneration (AMD)
A Phase 1 study testing vitrectomy with subretinal lucentis in people with Retinal Hemorrhage and Macular Degeneration, run by Corewell Health East at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Retinal Hemorrhage, Macular Degeneration
- What is being tested?
- vitrectomy with subretinal lucentis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Oct 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Use of Subretinal Ranibizumab (Lucentis) in the Management of Submacular Hemorrhage in Neovascular Age-Related Macular Degeneration (AMD)
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.
Read more
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.
Read the 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.
- Conditions
- Retinal Hemorrhage, Macular Degeneration
- Being tested
- vitrectomy with subretinal lucentis
- Keywords
- Macular Degeneration, AMD, Hemorrhage, Wet AMD
- Medical subject headings
- Retinal Hemorrhage, Macular Degeneration, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitrectomy with subretinal lucentisDrug
A gas bubble will be placed in the eye after the gel has been removed.
vitrectomy with subretinal lucentisDrug
These patients will have a vitrectomy where the gel is removed but will not receive the gas bubble.
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Does not receive Gas bubble Receives: Drug: vitrectomy with subretinal lucentis |
| B | Active comparator | Does receive gas bubble Receives: Drug: vitrectomy with subretinal lucentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionOct 2008 (estimated)
- Study completionOct 2008 (estimated)
Why it stopped: This condition can now be managed in the office with an injection of Lucentis.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Investigators
- Tarek Hassan, MD, Principal investigator, Associated Retinal Consultants/William Beaumont Hosp.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00538538
- Sponsor's protocol ID
- HIC 2007-073
- Status last verified
- Aug 2016
- First submitted
- 1 Oct 2007
- Last updated
- 8 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Subretinal Ranibizumab (Lucentis) in the Management of Submacular Hemorrhage in Neovascular Age-Related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT00538538
- Acronym / sponsor ID
- HIC 2007-073
- Conditions
- Retinal Hemorrhage, Macular Degeneration
- Keywords
- Macular Degeneration, AMD, Hemorrhage, Wet AMD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This condition can now be managed in the office with an injection of Lucentis.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Oct 2008 (estimated)
- Study completion
- Oct 2008 (estimated)
- First posted
- 2 Oct 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: vitrectomy with subretinal lucentisDoes not receive Gas bubble |
| B | Active comparator | Drug: vitrectomy with subretinal lucentisDoes receive gas bubble |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vitrectomy with subretinal lucentisA gas bubble will be placed in the eye after the gel has been removed. | Drug | B |
| vitrectomy with subretinal lucentisThese patients will have a vitrectomy where the gel is removed but will not receive the gas bubble. | Drug | A |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tarek Hassan, MD principal investigator
Associated Retinal Consultants/William Beaumont Hosp.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing vitrectomy with subretinal lucentis in people with Retinal Hemorrhage and Macular Degeneration, run by Corewell Health East at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2016.