Corneal NeovascularizationPhase 1NCT00681889
Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)
A Phase 1 study testing Ranibizumab in people with Corneal Neovascularization, run by Reza Dana, MD at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness and safety of ranibizumab (Lucentis) in treatment of corneal neovascularization. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Neovascularization
- What is being tested?
- Ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2008to Sep 2010
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
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 > 18 years old
- Patients with superficial or deep corneal neovascularization that extends farther than 2 mm from the limbus
Who cannot join
- Has received investigational therapy within 60 days prior to study entry
- Has received treatment with anti-VEGF agents (intraocular or systemic) within 45 days of study entry
- Concurrent use of systemic anti-VEGF agents
- Full thickness or lamellar keratoplasty within 90 days prior to study entry
- Ocular surface reconstruction within 90 days prior to study entry
- Other ocular surgeries within 90 days prior to study entry
Show all 17Show fewer
- Corneal or ocular surface infection within 90 days prior to study entry
- Ocular or periocular malignancy
- Contact lens (excluding bandage contact lens) within 30 days prior to study entry
- Persistent epithelial defect (>1mm2 and ≥14 days duration) within 30 days prior to study entry
- Systemic, intravitreal, or periocular steroids within 30 days prior to study entry
- Change in dose/frequency of topical steroids and/or NSAIDs within 30 days prior to study entry
- Hypertension: systolic BP > 150 or diastolic BP > 90
- History of thromboembolic event within 6 months prior to study entry
- Current diagnosis of diabetes, Pregnancy (positive pregnancy test) or lactation
- Premenopausal women not using adequate contraception (The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch)
- Participation in another simultaneous medical investigation or trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
About this study
The purpose of this study is to determine the effectiveness and safety of ranibizumab (Lucentis) in treatment of corneal neovascularization.
Read the detailed description
This is an open label, single site, uncontrolled, single group assignment, safety/efficacy, Phase I study of topical administered ranibizumab in subjects with corneal neovascularization. Ten eyes of patients with corneal neovascularization will be recruited. Patients with superficial or deep corneal neovascularization that extends farther than 2 mm from the limbus will be considered.
- Conditions
- Corneal Neovascularization
- Being tested
- Ranibizumab
- Medical subject headings
- Corneal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
10 Patients will receive treatment (Ranibizumab)
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | 10 Patients will receive treatment (Ranibizumab) Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and Severity of Ocular Adverse Event
Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing
Measured: 16 Weeks
Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs
Measured: 16 Weeks
Secondary outcomes (2)
Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs
Measured: Prospective
Efficacy by Measuring Mean Change of BCVA
Measured: Prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Corneal 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reza Dana, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Reza Dana, MD, Massachusetts Eye and Ear Infirmary
- Investigators
- Reza Dana, M.D., MPH, Principal investigator, Massachusetts Eye and Ear Infirmary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681889
- Sponsor's protocol ID
- 07-11-069
- Other IDs
- 07-11-069
- Status last verified
- Oct 2012
- First submitted
- 19 May 2008
- Last updated
- 8 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)
- ClinicalTrials.gov ID
- NCT00681889
- Acronym / sponsor ID
- 07-11-069
- Conditions
- Corneal Neovascularization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Reza Dana, MDUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 21 May 2008 (estimated)
- Results
- Posted 8 Nov 2012
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 the effectiveness and safety of ranibizumab (Lucentis) in treatment of corneal neovascularization.
Detailed description
This is an open label, single site, uncontrolled, single group assignment, safety/efficacy, Phase I study of topical administered ranibizumab in subjects with corneal neovascularization. Ten eyes of patients with corneal neovascularization will be recruited. Patients with superficial or deep corneal neovascularization that extends farther than 2 mm from the limbus will be considered.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Ranibizumab10 Patients will receive treatment (Ranibizumab) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 18 years old
- Patients with superficial or deep corneal neovascularization that extends farther than 2 mm from the limbus
Key exclusion criteria (17 listed)
- Has received investigational therapy within 60 days prior to study entry
- Has received treatment with anti-VEGF agents (intraocular or systemic) within 45 days of study entry
- Concurrent use of systemic anti-VEGF agents
- Full thickness or lamellar keratoplasty within 90 days prior to study entry
- Ocular surface reconstruction within 90 days prior to study entry
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 |
|---|---|---|
| RanibizumabAlso: Lucentis10 Patients will receive treatment (Ranibizumab) | Drug | Treatment Arm |
Primary outcome
Incidence and Severity of Ocular Adverse Event
Time frame: 16 Weeks
Incidence and severity of ocular adverse events, as identified by eye examination and visual acuity testing
Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs
Time frame: 16 Weeks
2 secondary outcomes
Efficacy by Comparison Size and Extent of Blood Vessels in Baseline and Follow-up Corneal Photographs
Time frame: Prospective
Efficacy by Measuring Mean Change of BCVA
Time frame: Prospective
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Corneal Neovascularization
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Corneal Crosslinking for Treatment of Corneal Neovascularization
Corneal Neovascularization
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Fine-needle Diathermy Combined With Subconjunctival Bevacizumab for Corneal Neovascularization
Corneal Neovascularisation
RecruitingPhase 1/2
Clinical Study of Intrastromal Anti-VEGF Injection for Corneal Neovascularization.
Herpes Simplex Keratitis, Corneal Neovascularization
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.
Reza Dana, M.D., MPH principal investigator
Massachusetts Eye and Ear Infirmary
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 Ranibizumab in people with Corneal Neovascularization, run by Reza Dana, MD 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 3 inclusion and 17 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 8 Nov 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.
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?
Yes. Results are posted in the registry (first posted 8 Nov 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence and Severity of Ocular Adverse Event (time frame: 16 Weeks). The study lists 2 primary outcomes in all. 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 Nov 2012.