Corneal NeovascularizationPhase 1NCT00559936
Topical Avastin for Treatment of Corneal Neovascularization
A Phase 1 study testing Topical Avastin 1% in people with Corneal Neovascularization, run by Massachusetts Eye and Ear Infirmary at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness and safety of Topical Bevacizumab (Avastin) for treatment of corneal neovascularization. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Corneal Neovascularization
- What is being tested?
- Topical Avastin 1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Oct 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, at least 18 years of age
- Clinical stable corneal neovascularization (as defined above)
- Ability to understand and provide informed consent to participate in this study and willingness to follow study instructions and likely to complete all required visits.
- All female patients of childbearing potential will be excluded. A female is considered to be of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries.
Who cannot join
- Current or recent (≤ 1 month) systemic corticosteroid therapy or periocular corticosteroid injections to the study eye
- Current or recent (≤ 3 months) intravitreal drug injection to the study eye; recent (≤ 1 month) change in dose and frequency of topical steroids and/or non-steroidal anti-inflammatory agents
- Uncontrolled hypertension defined as systolic blood pressure of ≥ 150 mmHg or diastolic blood pressure of ≥ 90 mmHg; history of a thromboembolic event, including myocardial infarction or cerebral vascular accident
- Patients age 75 or older; history of renal abnormalities
- Recent (≤ 3 months ) or planned surgery
- History of coagulation abnormalities, including end stage liver disease or current anticoagulation medication other than aspirin (warfarin, heparin, enoxaparin, or similar anticoagulant agent)
- All female patients of childbearing potential (a female is considered to be of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries)
- Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
About this study
Official title: Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization
The purpose of this study is to determine the effectiveness and safety of Topical Bevacizumab (Avastin) for treatment of corneal neovascularization.
Read the detailed description
Primary outcomes measures included neovascular area (NA), defined as the area of the corneal vessels themselves; vessel caliber (VC), defined as the mean diameter of the corneal vessels; and invasion area (IA), defined as the fraction of the total cornea into which the vessels extend. The occurrence of ocular and systemic adverse events was closely monitored throughout the course of the study.
- Conditions
- Corneal Neovascularization
- Being tested
- Topical Avastin 1%
- Medical subject headings
- Corneal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Avastin 1%Drug
Also called bevacizumab
Avastin (bevacizumab) 1%
| Study group | Role | What they receive |
|---|---|---|
| Topical Avastin 1.0% | Experimental | Each patient will receive topical Avastin in one eye. Receives: Drug: Topical Avastin 1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study.
The efficacy of bevacizumab in the treatment of corneal NV was evaluated by comparing corneal photographs taken at baseline with corneal photographs taken at the follow-up visits. Percent change from baseline was measured.
Measured: Six Months
Ocular and Systemic Safety
The occurrence of ocular and systemic adverse events was closely monitored over the course of this study. Ocular adverse events were monitored through complete ocular examinations including visual acuity measurement, intraocular pressure measurement, biomicroscopy, and corneal fluorescein staining. Systemic adverse events were identified with physical examinations, patient questioning, and blood pressure measurements taken throughout the study period.
Measured: All study visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startFeb 2007
- Primary completionOct 2010
- Study completionOct 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.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts Eye and Ear Infirmary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal 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
- NCT00559936
- Sponsor's protocol ID
- 06-12-077
- Other IDs
- 06-12-077
- Status last verified
- Apr 2022
- First submitted
- 14 Nov 2007
- Last updated
- 29 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Cheng SF, Dastjerdi MH, Ferrari G, Okanobo A, Bower KS, Ryan DS, Amparo F, Stevenson W, Hamrah P, Nallasamy N, Dana R. Short-term topical bevacizumab in the treatment of stable corneal neovascularization. Am J Ophthalmol. 2012 Dec;154(6):940-948.e1. doi: 10.1016/j.ajo.2012.06.007. Epub 2012 Sep 8.
PubMed 22967868Dastjerdi MH, Al-Arfaj KM, Nallasamy N, Hamrah P, Jurkunas UV, Pineda R 2nd, Pavan-Langston D, Dana R. Topical bevacizumab in the treatment of corneal neovascularization: results of a prospective, open-label, noncomparative study. Arch Ophthalmol. 2009 Apr;127(4):381-9. doi: 10.1001/archophthalmol.2009.18.
PubMed 19365012
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Topical Bevacizumab (Avastin) for Treatment of Corneal Neovascularization
- ClinicalTrials.gov ID
- NCT00559936
- Acronym / sponsor ID
- 06-12-077
- Conditions
- Corneal Neovascularization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Massachusetts Eye and Ear InfirmaryUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 16 Nov 2007 (estimated)
- Results
- Posted 24 Sep 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 Topical Bevacizumab (Avastin) for treatment of corneal neovascularization.
Detailed description
Primary outcomes measures included neovascular area (NA), defined as the area of the corneal vessels themselves; vessel caliber (VC), defined as the mean diameter of the corneal vessels; and invasion area (IA), defined as the fraction of the total cornea into which the vessels extend. The occurrence of ocular and systemic adverse events was closely monitored throughout the course of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Topical Avastin 1.0% | Experimental | Drug: Topical Avastin 1%Each patient will receive topical Avastin in one eye. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, at least 18 years of age
- Clinical stable corneal neovascularization (as defined above)
- Ability to understand and provide informed consent to participate in this study and willingness to follow study instructions and likely to complete all required visits.
- All female patients of childbearing potential will be excluded. A female is considered to be of childbearing potential unless she is postmenopausal and without menses for 12 months or without a uterus and/or both ovaries.
Key exclusion criteria (8 listed)
- Current or recent (≤ 1 month) systemic corticosteroid therapy or periocular corticosteroid injections to the study eye
- Current or recent (≤ 3 months) intravitreal drug injection to the study eye; recent (≤ 1 month) change in dose and frequency of topical steroids and/or non-steroidal anti-inflammatory agents
- Uncontrolled hypertension defined as systolic blood pressure of ≥ 150 mmHg or diastolic blood pressure of ≥ 90 mmHg; history of a thromboembolic event, including myocardial infarction or cerebral vascular accident
- Patients age 75 or older; history of renal abnormalities
- Recent (≤ 3 months ) or planned surgery
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 |
|---|---|---|
| Topical Avastin 1%Also: bevacizumabAvastin (bevacizumab) 1% | Drug | Topical Avastin 1.0% |
Primary outcome
The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study.
Time frame: Six Months
The efficacy of bevacizumab in the treatment of corneal NV was evaluated by comparing corneal photographs taken at baseline with corneal photographs taken at the follow-up visits. Percent change from baseline was measured.
Ocular and Systemic Safety
Time frame: All study visits
The occurrence of ocular and systemic adverse events was closely monitored over the course of this study. Ocular adverse events were monitored through complete ocular examinations including visual acuity measurement, intraocular pressure measurement, biomicroscopy, and corneal fluorescein staining. Systemic adverse events were identified with physical examinations, patient questioning, and blood pressure measurements taken throughout the study period.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 22967868Cheng SF, Dastjerdi MH, Ferrari G, Okanobo A, Bower KS, Ryan DS, Amparo F, Stevenson W, Hamrah P, Nallasamy N, Dana R. Short-term topical bevacizumab in the treatment of stable corneal neovascularization. Am J Ophthalmol. 2012 Dec;154(6):940-948.e1. doi: 10.1016/j.ajo.2012.06.007. Epub 2012 Sep 8.
- Derived from this study: PubMed 19365012Dastjerdi MH, Al-Arfaj KM, Nallasamy N, Hamrah P, Jurkunas UV, Pineda R 2nd, Pavan-Langston D, Dana R. Topical bevacizumab in the treatment of corneal neovascularization: results of a prospective, open-label, noncomparative study. Arch Ophthalmol. 2009 Apr;127(4):381-9. doi: 10.1001/archophthalmol.2009.18.
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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.
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 Topical Avastin 1% in people with Corneal Neovascularization, run by Massachusetts Eye and Ear Infirmary 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 4 inclusion and 8 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 29 Apr 2022. 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 24 Sep 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?
The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study. (time frame: Six Months). 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?
On the ClinicalTrials.gov record for NCT00559936, which also lists 2 linked publications.
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 29 Apr 2022.