Choroidal MelanomaPhase 2NCT01251978
Ranibizumab as Adjuvant Therapy for the Treatment of Choroidal Melanoma (Cohort 2)
A Phase 2 study testing Ranibizumab 2 mg and 0.5 mg Ranibizumab in people with Choroidal Melanoma, run by New England Retina Associates at 1 site in United States.
Trial summary
Ranibizumab has proven to be of benefit to improve the perfusion in the retina of patients with Choroidal Melanoma. The investigators consider that higher doses of Ranibizumab can help reduce the number of laser treatments that might be needed to control the tumor. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Choroidal Melanoma
- What is being tested?
- Ranibizumab 2 mg and 0.5 mg Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Aug 2012
- Phase
- Phase 2
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Primary pigmented or amelanotic choroidal melanoma measuring 16 mm or less in the largest basal diameter and 6 mm or less in the apical height.
- Location of the tumor, posterior to the equator of the eye.
- Documented growth of tumor by A-B scan.
- Ability to provide written informed consent and comply with the study assessment for the full duration of the study.
Who cannot join
- Pregnancy or lactation.
- Premenopausal women not using adequate contraception.
- Current infection or inflammation in either eye.
- Extension of tumor into the orbit.
- Regional spread or metastatic disease.
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
- Any known allergy to any of the components to be used in the study.
- Participation in another simultaneous medical investigation or trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
New England Retina Associates
Hamden, Connecticut, 06518
About this study
Official title: Phase 2 Study to Evaluate the Efficacy of High Dose Ranibizumab as Adjuvant in the Treatment of Choroidal Melanoma
Ranibizumab has proven to be of benefit to improve the perfusion in the retina of patients with Choroidal Melanoma. The investigators consider that higher doses of Ranibizumab can help reduce the number of laser treatments that might be needed to control the tumor.
- Conditions
- Choroidal Melanoma
- Being tested
- Ranibizumab 2 mg, 0.5 mg Ranibizumab
- Keywords
- Choroidal melanoma, Ranibizumab, Transpupillary Thermotherapy, CSTIP, Indocyanine Green
- Medical subject headings
- Uveal Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab 2 mgDrug
intravitreal injections of ranibizumab once a month, times 3.
0.5 mg RanibizumabDrug
6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months.
| Study group | Role | What they receive |
|---|---|---|
| High dose Ranibizumab | Active comparator | 6 patients will receive 3 injections of Ranibizumab (2 mg) a month apart. Receives: Drug: Ranibizumab 2 mg |
| Standard Dose Ranibizumab | Active comparator | 6 patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months. Receives: Drug: 0.5 mg Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.
Measured: 1 year
Secondary outcomes (2)
Tumor Thickness
Measured: baseline and 1 year
Visual Acuity (LogMar)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2010 (estimated)
- Study startJul 2010
- Primary completionJul 2012
- Study completionAug 2012
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 Choroidal MelanomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- New England Retina Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Genentech, Inc.
- Responsible party
- Sponsor
- Investigators
- Peter E Liggett, MD, Principal investigator, New England Retina Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251978
- Sponsor's protocol ID
- FVF4927s
- Status last verified
- Oct 2016
- First submitted
- 30 Nov 2010
- Last updated
- 19 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study to Evaluate the Efficacy of High Dose Ranibizumab as Adjuvant in the Treatment of Choroidal Melanoma
- ClinicalTrials.gov ID
- NCT01251978
- Acronym / sponsor ID
- FVF4927s
- Conditions
- Choroidal Melanoma
- Keywords
- Choroidal melanoma, Ranibizumab, Transpupillary Thermotherapy, CSTIP, Indocyanine Green
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- New England Retina AssociatesUniversity, hospital or other
- Collaborators
- Genentech, Inc.
- Study start
- Jul 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 2 Dec 2010 (estimated)
- Results
- Posted 19 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Ranibizumab has proven to be of benefit to improve the perfusion in the retina of patients with Choroidal Melanoma. The investigators consider that higher doses of Ranibizumab can help reduce the number of laser treatments that might be needed to control the tumor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose Ranibizumab | Active comparator | Drug: Ranibizumab 2 mg6 patients will receive 3 injections of Ranibizumab (2 mg) a month apart. |
| Standard Dose Ranibizumab | Active comparator | Drug: 0.5 mg Ranibizumab6 patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years or older
- Primary pigmented or amelanotic choroidal melanoma measuring 16 mm or less in the largest basal diameter and 6 mm or less in the apical height.
- Location of the tumor, posterior to the equator of the eye.
- Documented growth of tumor by A-B scan.
- Ability to provide written informed consent and comply with the study assessment for the full duration of the study.
Key exclusion criteria (8 listed)
- Pregnancy or lactation.
- Premenopausal women not using adequate contraception.
- Current infection or inflammation in either eye.
- Extension of tumor into the orbit.
- Regional spread or metastatic disease.
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 |
|---|---|---|
| Ranibizumab 2 mgintravitreal injections of ranibizumab once a month, times 3. | Drug | High dose Ranibizumab |
| 0.5 mg Ranibizumab6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months. | Drug | Standard Dose Ranibizumab |
Primary outcome
To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications.
Time frame: 1 year
2 secondary outcomes
Tumor Thickness
Time frame: baseline and 1 year
Visual Acuity (LogMar)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- New England Retina Associates website. It contains all the clinical trials that we are running.Link provided by the sponsor.
Related trials for Choroidal Melanoma
Active, not recruitingObservational study
Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects
Choroidal Melanoma, Indeterminate Lesions
Active, not recruitingPhase 2
Sunitinib Malate or Valproic Acid in Preventing Metastasis in Patients With High-Risk Uveal Melanoma
Ciliary Body and Choroid Melanoma, Medium/Large Size, Ciliary Body and Choroid Melanoma, Small Size
Active, not recruitingPhase 3
A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma
Choroidal Melanoma, Indeterminate Lesions
RecruitingPhase 3
Study of Adjuvant Darovasertib and Crizotinib in Participants With Primary Non-metastatic Uveal Melanoma
Uveal Melanoma
Enrolling by invitationObservational study
A Long-Term Follow-Up Study of Subjects Completing the AU-011-301(CoMpass) for Early Choroidal Melanoma
Choroidal Melanoma, Indeterminate Lesions
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.
Peter E Liggett, MD principal investigator
New England Retina Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ranibizumab 2 mg and 0.5 mg Ranibizumab in people with Choroidal Melanoma, run by New England Retina Associates 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 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 19 Oct 2016. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 19 Oct 2016). 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?
To Evaluate the Safety/Efficacy of Intravitreal Injection of High Dose Ranibizumab Combined With TTT + ICG-based Photodynamic Therapy in the Treatment of Choroidal Melanoma by Reporting the Number of Participants With Complications. (time frame: 1 year). 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 19 Oct 2016.