Cystoid Macular EdemaFVF4153sNCT00464581
Lucentis for Treatment of Macular Edema
An observational study of Cystoid Macular Edema, run by Retina Institute of Hawaii at 1 site in United States.
Trial summary
Cystoid macular edema (CME) is the most common cause of suboptimal post-operative visual acuity in uncomplicated cataract extractions. Over two million cataract extractions are performed each year, with a reported incidence ranging from 1.5 to 6.9%, resulting in an estimated 20,000-130,000 new cases of CME annually. Read more about this study
- Who is it for?
- Ages Up to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystoid Macular Edema
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Dec 2009
- Phase
- Observational
- 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 Up to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with Macular Edema
Who may be able to join
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age < 90 years
- Cystoid macular edema, documented by FFA
- Best corrected visual acuity in the study eye between 85 and 20 ETDRS letters or between 20/30 and 20/800 in a Snellen chart.
- Women must be using two forms of effective contraception, be post¬menopausal for at least 12 months prior to trial entry, or surgically sterile; if of child-bearing potential, a urine pregnancy test must be performed within 7 days prior to the first injection with a negative result. If the test is positive, a serum test must be done to confirm. The two forms of effective contraception must be implemented during the trial and for at least 60 days following the last dose of test medication.
Who cannot join
- Significant media opacities, which might interfere with visual acuity.
- Any ocular or periocular infection in the past 4 weeks.
- Presence of pigment epithelial tears or rips.
- Any of the following underlying diseases including:
- Diabetic retinopathy.
- History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV - see Appendix 16.6), clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months, ventricular tachyarrhythmias requiring ongoing treatment.
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- History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation.
- History or evidence of clinically significant impaired renal or hepatic function
- Stroke (within 12 months of trial entry).
- Any major surgical procedure within one month of trial entry.
- Previous therapeutic radiation in the region of the study eye.
- Any treatment with an investigational agent in the past 30 days for any condition.
- Known serious allergies to the fluorescein dye used in angiography or to the components of ranibizumab formulation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center Phase 2 Trial of Intravitreous Injections of Lucentis (Ranibizumab) in Subjects With Cystoid Macular Edema Secondary to Non-ischemic Retinopathy
Cystoid macular edema (CME) is the most common cause of suboptimal post-operative visual acuity in uncomplicated cataract extractions. Over two million cataract extractions are performed each year, with a reported incidence ranging from 1.5 to 6.9%, resulting in an estimated 20,000-130,000 new cases of CME annually. Clinical CME historically was associated with visual acuity of 20/40 or worse with fluorescein angiographic evidence of macular edema in a classic petaloid pattern. Angiographic CME physiologically signals an inflammatory process causing distortion of the outer plexiform layer, which if not resolved quickly could result in non-repairable visual loss. Topical, periocular, or intravitreal corticosteroids, despite their associated side effects, are the mainstay for pharmacologic treatment for patients with CME. Their efficacy has never been demonstrated in a randomized, controlled and blinded study.
This is an open-label, Phase II study of intravitreally administered ranibizumab in subjects with cystoid macular edema secondary to non-ischemic retinopathy, as seen following cataract surgery with intraocular lens implantation.
Read the detailed description
Vascular endothelial growth factor (VEGF) is known to be induced by hypoxia and has been implicated in the development of iris and retinal vascularization. VEGF, however, is also known to be a potent mediator of vascular permeability in other tissues and may perform this function in retina.
Immunohistochemical VEGF staining has been identified in patients with disorders such as aphakic and pseudophakic cystoid macular edema, ocular inflammatory disease and infection. VEGF was primarily localized within retinal neurons and within the retinal pigment epithelium in these cases. In addition or in association with its role of inducing neovascularization (Wet AMD and diabetic retinopathy, VEGF may contribute to the breakdown of the blood-retinal barrier in a variety of disorders.
Ranibizumab is a pan-VEGF A blocker that has been proven highly effective for the treatment of wet macular degeneration. The underlying pathophysiology of both cystoid macular edema and wet AMD is VEGF overproduction.
To date ranibizumab has been approved only for treating wet ARMD. In this study we will explore ranibizumab for the treatment of cystoid macular edema It is hypothesized that this population will show dramatic improvement as the initial cause of VEGF production can be isolated to the surgical procedure and due to the fact that the retinal pigment epithelium is healthier in this population as compared to the macular degeneration counterparts.
- Conditions
- Cystoid Macular Edema
- Keywords
- non-ischemic retinopathy
- Medical subject headings
- Macular Edema
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of ranibizumab in patients with CME secondary to non-ischemic retinopathy
Measured: 2 years
Secondary outcomes (7)
Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart, at each month of months 0-12.
Measured: 2 years
Proportion of subjects who remained at baseline VA or gained >0 lines of vision from baseline to week 24 and 52.
Measured: 2 years
Mean change in central retinal thickness on OCT 3 from Baseline to week 24 and 52.
Measured: 2 years
Changes observed on the Fluoreosceiien Angiographs from baseline to week 24 and 52.
Measured: 2 years
Mean number of ranibizumab injections required.
Measured: 2 years
Nidek MPI measurements taken at baseline, week 24, and week 52
Measured: 2 years
Proportion of subjects who demonstrate complete resolution of macular edema as seen on OCT testing from baseline to week 52
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2007 (estimated)
- Study startMay 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystoid Macular EdemaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Retina Institute of Hawaii
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Debbie Shimabukuro, Retina Institute of Hawaii
- Investigators
- Michael D Bennett, MD, Principal investigator, Retina Institute of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00464581
- Sponsor's protocol ID
- FVF-4153s
- Acronym
- FVF4153s
- Status last verified
- May 2012
- First submitted
- 19 Apr 2007
- Last updated
- 28 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Phase 2 Trial of Intravitreous Injections of Lucentis (Ranibizumab) in Subjects With Cystoid Macular Edema Secondary to Non-ischemic Retinopathy
- ClinicalTrials.gov ID
- NCT00464581
- Acronym / sponsor ID
- FVF4153s / FVF-4153s
- Conditions
- Cystoid Macular Edema
- Keywords
- non-ischemic retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Retina Institute of HawaiiUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- May 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Apr 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.
Cystoid macular edema (CME) is the most common cause of suboptimal post-operative visual acuity in uncomplicated cataract extractions. Over two million cataract extractions are performed each year, with a reported incidence ranging from 1.5 to 6.9%, resulting in an estimated 20,000-130,000 new cases of CME annually. Clinical CME historically was associated with visual acuity of 20/40 or worse with fluorescein angiographic evidence of macular edema in a classic petaloid pattern. Angiographic CME physiologically signals an inflammatory process causing distortion of the outer plexiform layer, which if not resolved quickly could result in non-repairable visual loss. Topical, periocular, or intravitreal corticosteroids, despite their associated side effects, are the mainstay for pharmacologic treatment for patients with CME. Their efficacy has never been demonstrated in a randomized, controlled and blinded study.
This is an open-label, Phase II study of intravitreally administered ranibizumab in subjects with cystoid macular edema secondary to non-ischemic retinopathy, as seen following cataract surgery with intraocular lens implantation.
Detailed description
Vascular endothelial growth factor (VEGF) is known to be induced by hypoxia and has been implicated in the development of iris and retinal vascularization. VEGF, however, is also known to be a potent mediator of vascular permeability in other tissues and may perform this function in retina.
Immunohistochemical VEGF staining has been identified in patients with disorders such as aphakic and pseudophakic cystoid macular edema, ocular inflammatory disease and infection. VEGF was primarily localized within retinal neurons and within the retinal pigment epithelium in these cases. In addition or in association with its role of inducing neovascularization (Wet AMD and diabetic retinopathy, VEGF may contribute to the breakdown of the blood-retinal barrier in a variety of disorders.
Ranibizumab is a pan-VEGF A blocker that has been proven highly effective for the treatment of wet macular degeneration. The underlying pathophysiology of both cystoid macular edema and wet AMD is VEGF overproduction.
To date ranibizumab has been approved only for treating wet ARMD. In this study we will explore ranibizumab for the treatment of cystoid macular edema It is hypothesized that this population will show dramatic improvement as the initial cause of VEGF production can be isolated to the surgical procedure and due to the fact that the retinal pigment epithelium is healthier in this population as compared to the macular degeneration counterparts.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Macular Edema
Key inclusion criteria (5 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age < 90 years
- Cystoid macular edema, documented by FFA
- Best corrected visual acuity in the study eye between 85 and 20 ETDRS letters or between 20/30 and 20/800 in a Snellen chart.
- Women must be using two forms of effective contraception, be post¬menopausal for at least 12 months prior to trial entry, or surgically sterile; if of child-bearing potential, a urine pregnancy test must be performed within 7 days prior to the first injection with a negative result. If the test is positive, a serum test must be done to confirm. The two forms of effective contraception must be implemented during the trial and for at least 60 days following the last dose of test medication.
Key exclusion criteria (13 listed)
- Significant media opacities, which might interfere with visual acuity.
- Any ocular or periocular infection in the past 4 weeks.
- Presence of pigment epithelial tears or rips.
- Any of the following underlying diseases including:
- Previous therapeutic radiation in the region of the study eye.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To evaluate the safety and tolerability of ranibizumab in patients with CME secondary to non-ischemic retinopathy
Time frame: 2 years
7 secondary outcomes
Mean change in best corrected visual acuity (BCVA), as assessed by the number of letters read correctly on the ETDRS eye chart, at each month of months 0-12.
Time frame: 2 years
Proportion of subjects who remained at baseline VA or gained >0 lines of vision from baseline to week 24 and 52.
Time frame: 2 years
Mean change in central retinal thickness on OCT 3 from Baseline to week 24 and 52.
Time frame: 2 years
Changes observed on the Fluoreosceiien Angiographs from baseline to week 24 and 52.
Time frame: 2 years
Mean number of ranibizumab injections required.
Time frame: 2 years
Nidek MPI measurements taken at baseline, week 24, and week 52
Time frame: 2 years
Proportion of subjects who demonstrate complete resolution of macular edema as seen on OCT testing from baseline to week 52
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2012.
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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.
Michael D Bennett, MD principal investigator
Retina Institute of Hawaii
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystoid Macular Edema, run by Retina Institute of Hawaii 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 28 May 2012. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 evaluate the safety and tolerability of ranibizumab in patients with CME secondary to non-ischemic retinopathy (time frame: 2 years). 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 28 May 2012.