Iris NeovascularizationPhase 1NCT00295828
A Pilot Study for the Treatment of Iris Neovascularization With Macugen
A Phase 1 study testing Pegaptanib Sodium Injection/Panretinal Photocoagulation and Panretinal Photocoagulation (PRP) in people with Iris Neovascularization and Diabetic Retinopathy, run by Hermann Eye Center at 1 site in United States.
Trial summary
The purpose of this study is to determine if a drug called Macugen may help to stop the growth of abnormal blood vessels on the iris that has occurred in the eye(s) as part of diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Iris Neovascularization, Diabetic Retinopathy
- What is being tested?
- Pegaptanib Sodium Injection/Panretinal Photocoagulation and Panretinal Photocoagulation (PRP)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, at least 18 years of age
- Diabetic retinopathy with iris neovascularization
- Visual acuity must be light perception or better in the study eye
- Female patients of childbearing potential must have a negative urine pregnancy test at the screening visit.
- Written informed consent has been obtained
- Written authorization for use and release of health and research study information has been obtained
Who cannot join
- Neovascular glaucoma ( a difficult form of glaucoma to control that leads to a painful eye with high intraocular pressure, corneal swelling, and "cell and flare" in the anterior chamber. Caused by abnormal new blood vessel formation (neovascularization) on the iris, that extends over trabecular meshwork causing closure of angle drainage structures).
- No light perception in the study eye.
- Inadequate view of retina for PRP/angiography
- Anterior chamber intraocular lens implant
- PRP treatment in the past 60 days. Patients may participate if the PRP treatment is beyond 60 days and has newly diagnosed NVI or has nonregression of previously diagnosed NVI.
- Previous or current Macugen use
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- Any active ocular infection
- Any conditions which precludes patients ability to comply with study requirements including completion of the study
- Female patients who are pregnant, nursing, or planning pregnancy, or who are of childbearing potential and not using a reliable means of contraception
- Current enrollment in an investigational drug or device study or participation in such a study within 30 days prior to screening
- Patient has a condition or is in a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results or may interfere significantly with the patient's participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine if a drug called Macugen may help to stop the growth of abnormal blood vessels on the iris that has occurred in the eye(s) as part of diabetic retinopathy.
Read the detailed description
Diabetic retinopathy is an eye condition caused by diabetes in which new blood vessels grow on the retina (the back, inside part of the eye) and the iris. These vessels are not normal and may leak or break, causing bleeding in the eye. This process can lead to vision loss or blindness, glaucoma (disease of the eye where eye pressures are usually too high resulting in damage to the optic nerve), or other eye problems. This study is to determine if a drug called Macugen may help to stop the growth of these abnormal blood vessels on the iris.
- Conditions
- Iris Neovascularization, Diabetic Retinopathy
- Being tested
- Pegaptanib Sodium Injection/Panretinal Photocoagulation, Panretinal Photocoagulation (PRP)
- Keywords
- VEGF, iris neovascularization, diabetic retinopathy, Macugen
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegaptanib Sodium Injection/Panretinal PhotocoagulationOther
Also called Macugen
Pegaptanib Sodium Injection is a single dose prefilled syringe and is formulated as a 3.47 mg/mL solution. Combined with an ocular laser procedure.
Panretinal Photocoagulation (PRP)Procedure or surgery
Also called PRP
Ocular Laser Procedure
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Panretinal Photocoagulation (PRP) Receives: Procedure: Panretinal Photocoagulation (PRP) |
| 2 | Active comparator | Panretinal Photocoagulation and Macugen Intravitreal Injection Receives: Other: Pegaptanib Sodium Injection/Panretinal Photocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regression of iris neovascularization and prevention of development of neovascular glaucoma
Measured: prospective
Secondary outcomes (6)
Iris angiogram - conducted at screening/treatment visit,week 1, week 3, week 6, week 9, week 12, week 15, week 18, and week 52.
Measured: prospective
Regression will be determined by lack of leakage and/or lack of flow through the abnormal vessels.
Measured: prospective
Assessment of retina with dilated fundus examination for signs of neovascularization in posterior segment at each follow-up visit
Measured: prospective
The complete resolution of iris neovascularization, or regression to less than 2 clock hours of iris neovascularization.
Measured: prospective
A clinically significant reduction in the clock hours of angle neovascularization.
Measured: prospective
Development of neovascular glaucoma.
Measured: prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2006 (estimated)
- Study startJan 2006
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iris NeovascularizationStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hermann Eye Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eyetech Pharmaceuticals
- Investigators
- Robert M Feldman, MD, Principal investigator, Hermann Eye Fund & University of Texas -- Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00295828
- Sponsor's protocol ID
- HEF-0510
- Status last verified
- Sep 2008
- First submitted
- 22 Feb 2006
- Last updated
- 4 Sep 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study for the Treatment of Iris Neovascularization With Macugen
- ClinicalTrials.gov ID
- NCT00295828
- Acronym / sponsor ID
- HEF-0510
- Conditions
- Iris Neovascularization, Diabetic Retinopathy
- Keywords
- VEGF, iris neovascularization, diabetic retinopathy, Macugen
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hermann Eye CenterUniversity, hospital or other
- Collaborators
- Eyetech Pharmaceuticals
- Study start
- Jan 2006
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 24 Feb 2006 (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.
The purpose of this study is to determine if a drug called Macugen may help to stop the growth of abnormal blood vessels on the iris that has occurred in the eye(s) as part of diabetic retinopathy.
Detailed description
Diabetic retinopathy is an eye condition caused by diabetes in which new blood vessels grow on the retina (the back, inside part of the eye) and the iris. These vessels are not normal and may leak or break, causing bleeding in the eye. This process can lead to vision loss or blindness, glaucoma (disease of the eye where eye pressures are usually too high resulting in damage to the optic nerve), or other eye problems. This study is to determine if a drug called Macugen may help to stop the growth of these abnormal blood vessels on the iris.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Panretinal Photocoagulation (PRP)Panretinal Photocoagulation (PRP) |
| 2 | Active comparator | Other: Pegaptanib Sodium Injection/Panretinal PhotocoagulationPanretinal Photocoagulation and Macugen Intravitreal Injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, at least 18 years of age
- Diabetic retinopathy with iris neovascularization
- Visual acuity must be light perception or better in the study eye
- Female patients of childbearing potential must have a negative urine pregnancy test at the screening visit.
- Written informed consent has been obtained
Key exclusion criteria (11 listed)
- Neovascular glaucoma ( a difficult form of glaucoma to control that leads to a painful eye with high intraocular pressure, corneal swelling, and "cell and flare" in the anterior chamber. Caused by abnormal new blood vessel formation (neovascularization) on the iris, that extends over trabecular meshwork causing closure of angle drainage structures).
- No light perception in the study eye.
- Inadequate view of retina for PRP/angiography
- Anterior chamber intraocular lens implant
- PRP treatment in the past 60 days. Patients may participate if the PRP treatment is beyond 60 days and has newly diagnosed NVI or has nonregression of previously diagnosed NVI.
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 |
|---|---|---|
| Pegaptanib Sodium Injection/Panretinal PhotocoagulationAlso: MacugenPegaptanib Sodium Injection is a single dose prefilled syringe and is formulated as a 3.47 mg/mL solution. Combined with an ocular laser procedure. | Other | 2 |
| Panretinal Photocoagulation (PRP)Also: PRPOcular Laser Procedure | Procedure or surgery | 1 |
Primary outcome
Regression of iris neovascularization and prevention of development of neovascular glaucoma
Time frame: prospective
6 secondary outcomes
Iris angiogram - conducted at screening/treatment visit,week 1, week 3, week 6, week 9, week 12, week 15, week 18, and week 52.
Time frame: prospective
Regression will be determined by lack of leakage and/or lack of flow through the abnormal vessels.
Time frame: prospective
Assessment of retina with dilated fundus examination for signs of neovascularization in posterior segment at each follow-up visit
Time frame: prospective
The complete resolution of iris neovascularization, or regression to less than 2 clock hours of iris neovascularization.
Time frame: prospective
A clinically significant reduction in the clock hours of angle neovascularization.
Time frame: prospective
Development of neovascular glaucoma.
Time frame: prospective
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 4 Sep 2008.
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.
Robert M Feldman, MD principal investigator
Hermann Eye Fund & University of Texas -- Houston
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 Pegaptanib Sodium Injection/Panretinal Photocoagulation and Panretinal Photocoagulation (PRP) in people with Iris Neovascularization and Diabetic Retinopathy, run by Hermann Eye Center 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 6 inclusion and 11 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 4 Sep 2008. 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 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?
Regression of iris neovascularization and prevention of development of neovascular glaucoma (time frame: prospective). 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 4 Sep 2008.