Conjunctival NeoplasmsPhase 1NCT00456495
Effect of Ranibizumab on Malignant Conjunctival Neoplasia
A Phase 1 study testing ranibizumab in people with Conjunctival Neoplasms, run by The New York Eye Cancer Center at 1 site in United States.
Trial summary
The purpose of this study is to test the safety and tolerability of subconjunctival injection of ranibizumab in the treatment of malignant conjunctival neoplasia using the incidence and severity of adverse events. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Conjunctival Neoplasms
- What is being tested?
- ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2007to 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 21 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 > 21 years
- Tumors whose treatment with standard therapy would cause significant visual morbidity
- Diagnosis of biopsy proven malignant conjunctival neoplasia and are
- Recurrent disease
- Multi-focal disease
- Diffuse disease
Who cannot join
- Extension of tumor into eye or orbit.
- Regional spread or metastatic disease
- 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.
- Current infection or inflammation in either eye
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial
Trial locations and contacts
1 site in 1 country.
United States1 site
The New York Eye Cancer Center
New York, New York, 10021
About this study
The purpose of this study is to test the safety and tolerability of subconjunctival injection of ranibizumab in the treatment of malignant conjunctival neoplasia using the incidence and severity of adverse events.
Our secondary objective is to assess the efficacy of ranibizumab treatment on malignant conjunctival neoplasia by evaluating tumor destruction or reduction as documented by slit-lamp photography and ultrasonographic imaging and the regression of blood vessels.
Read the detailed description
Ranibizumab is a recently approved vascular endothelial growth factor (VEGF) inhibitor shown to be effective in treating exudative macular degeneration. Its analog, Avastin has also been employed to treat macular edema, proliferative diabetic retinopathy and wet age related macular degeneration. Ranibizumab binds to and inhibits vascular endothelial growth factor A (VEGF-A), which has been shown to cause neovascularization and leakage in models of ocular angiogenesis. Binding to VEGF-A prevents ranibizumab's interaction with VEGFR-1 and -2 receptors on the surface of endothelial cells, thereby reducing proliferation, vascular leakage, and angiogenesis.
Given that conjunctival tumors require the formation of new blood vessels to supply the proliferating cells, we propose a study to evaluate the effect of subconjunctival ranibizumab as a primary intervention in patients with conjunctival tumors.
- Conditions
- Conjunctival Neoplasms
- Being tested
- ranibizumab
- Medical subject headings
- Conjunctival Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
Also called Lucentis
Subconjunctival injection of drug every 2 to 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Subconjunctival ranibizumab | Experimental | Patients will receive subconjunctival ranibizumab every 2-4 weeks. Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients Assessed for Safety and Tolerability
To test the safety and tolerability of subconjunctival injection of ranibizumab in the treatment of malignant conjunctival neoplasia - using comparative slit lamp examination [anterior segment and ocular adnexal examination for adverse events (eg abrasion, melting), visual acuity (number of patients with decrease in visual acuity), and blood pressure at each visit (number of patients with increased blood pressure from baseline), and monthly urinalyis (number of patients with abnormal protein level in urine).
Measured: 2 years
Secondary outcomes (1)
Evaluating Tumor Destruction or Reduction
To evaluate the efficacy of treatment using comparative slit lamp examinations (anterior segment and ocular adnexal exam) to evaluate tumor volume, from baseline to month 12, and 24. To report on the number of patients with improvement in tumor volume.
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 posted5 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionSep 2010
- 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Conjunctival NeoplasmsStudies 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- The New York Eye Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Principal investigator, Paul T. Finger, MD, The New York Eye Cancer Center
- Investigators
- Paul T. Finger, MD, Principal investigator, The New York Eye Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00456495
- Sponsor's protocol ID
- 4192s
- Status last verified
- Jun 2017
- First submitted
- 3 Apr 2007
- Last updated
- 21 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Finger PT, Chin KJ. Refractory squamous cell carcinoma of the conjunctiva treated with subconjunctival ranibizumab (Lucentis): a two-year study. Ophthalmic Plast Reconstr Surg. 2012 Mar-Apr;28(2):85-9. doi: 10.1097/IOP.0b013e3182392f29.
PubMed 22186988
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ranibizumab on Malignant Conjunctival Neoplasia
- ClinicalTrials.gov ID
- NCT00456495
- Acronym / sponsor ID
- 4192s
- Conditions
- Conjunctival Neoplasms
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- The New York Eye Cancer CenterUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Mar 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 5 Apr 2007 (estimated)
- Results
- Posted 6 Jun 2013
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 test the safety and tolerability of subconjunctival injection of ranibizumab in the treatment of malignant conjunctival neoplasia using the incidence and severity of adverse events.
Our secondary objective is to assess the efficacy of ranibizumab treatment on malignant conjunctival neoplasia by evaluating tumor destruction or reduction as documented by slit-lamp photography and ultrasonographic imaging and the regression of blood vessels.
Detailed description
Ranibizumab is a recently approved vascular endothelial growth factor (VEGF) inhibitor shown to be effective in treating exudative macular degeneration. Its analog, Avastin has also been employed to treat macular edema, proliferative diabetic retinopathy and wet age related macular degeneration. Ranibizumab binds to and inhibits vascular endothelial growth factor A (VEGF-A), which has been shown to cause neovascularization and leakage in models of ocular angiogenesis. Binding to VEGF-A prevents ranibizumab's interaction with VEGFR-1 and -2 receptors on the surface of endothelial cells, thereby reducing proliferation, vascular leakage, and angiogenesis.
Given that conjunctival tumors require the formation of new blood vessels to supply the proliferating cells, we propose a study to evaluate the effect of subconjunctival ranibizumab as a primary intervention in patients with conjunctival tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subconjunctival ranibizumab | Experimental | Drug: ranibizumabPatients will receive subconjunctival ranibizumab every 2-4 weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to provide written informed consent and comply with study assessments for the full duration of the study
- Age > 21 years
- Tumors whose treatment with standard therapy would cause significant visual morbidity
- Diagnosis of biopsy proven malignant conjunctival neoplasia and are
- Recurrent disease
Key exclusion criteria (7 listed)
- Extension of tumor into eye or orbit.
- Regional spread or metastatic disease
- 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.
- Current infection or inflammation in either eye
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: LucentisSubconjunctival injection of drug every 2 to 4 weeks | Drug | Subconjunctival ranibizumab |
Primary outcome
Number of Patients Assessed for Safety and Tolerability
Time frame: 2 years
To test the safety and tolerability of subconjunctival injection of ranibizumab in the treatment of malignant conjunctival neoplasia - using comparative slit lamp examination [anterior segment and ocular adnexal examination for adverse events (eg abrasion, melting), visual acuity (number of patients with decrease in visual acuity), and blood pressure at each visit (number of patients with increased blood pressure from baseline), and monthly urinalyis (number of patients with abnormal protein level in urine).
1 secondary outcome
Evaluating Tumor Destruction or Reduction
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22186988Finger PT, Chin KJ. Refractory squamous cell carcinoma of the conjunctiva treated with subconjunctival ranibizumab (Lucentis): a two-year study. Ophthalmic Plast Reconstr Surg. 2012 Mar-Apr;28(2):85-9. doi: 10.1097/IOP.0b013e3182392f29.
- Individual participant dataSharing planned: No
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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.
Paul T. Finger, MD principal investigator
The New York Eye Cancer Center
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 Conjunctival Neoplasms, run by The New York Eye Cancer 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 7 inclusion and 7 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 21 Jul 2017. 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 6 Jun 2013). 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?
Number of Patients Assessed for Safety and Tolerability (time frame: 2 years). 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 NCT00456495, which also lists 1 linked publication.
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 21 Jul 2017.