Clinically Significant Diabetic Macular EdemaPhase 1/2NCT00440609
Study Comparing 0.5mg of Ranibizumab and Higher Doses in the Treatment of Clinically Significant Diabetic Macular Edema
A Phase 1/2 study testing ranibizumab in people with Clinically Significant Diabetic Macular Edema, run by Philip J. ferrone, M.D. at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of Ranibizumab in patients with Clinically Significant Diabetic Macular Edema (CSDME). It will also compare treatment outcomes for patients receiving 0.5mg Ranibizumab and higher doses of 1.0mg and 2.0mg Ranibizumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clinically Significant Diabetic Macular Edema
- 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
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2007to Dec 2012
- Phase
- Phase 1/2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type I or Type II diabetic subjects
- Vision between 20/20 and 20/400
- Presence of Clinically Significant Diabetic Macular Edema
Who cannot join
- Presence of any condition that would prevent clear visualization of the back of the eye
- Uncontrolled glaucoma
- Complications of glaucoma
- Inflammation inside the eye
- Certain prior eye surgeries, other than cataract surgery
- Other eye diseases that may compromise the vision in the study eye
Show all 12Show fewer
- Certain prior eye treatments
- Pregnancy
- Uncontrolled health conditions
- History of heart attack
- History of stroke
- Current participation in another investigational trial
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Long Island Vitreoretinal Consultants
Great Neck, New York, 11021
Long Island Vitreoretinal Consultants
Hauppauge, New York, 11749
About this study
Official title: A Phase I/II Study Comparing the Treatment of Clinically Significant Diabetic Macular Edema (CSDME) With 0.5mg Ranibizumab, 1.0mg Ranibizumab and 2.0mg Ranibizumab
The purpose of this study is to evaluate the safety and tolerability of Ranibizumab in patients with Clinically Significant Diabetic Macular Edema (CSDME). It will also compare treatment outcomes for patients receiving 0.5mg Ranibizumab and higher doses of 1.0mg and 2.0mg Ranibizumab.
- Being tested
- ranibizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
0.5mg or 1.0mg intravitreal injection given monthly for 3 months then every other month if needed, for the first year.Patients may be treated monthly as needed. Patients in Cohort 1(the first 30 patients)will be eligible to receive treatment as needed with 2.0mg ranibizumab starting at month 24. Patients in Cohort 2(the remaining 20)will be eligible to receive treatment as needed with 2.0mg ranibizumab starting at month 12.Patients may receive 2.0mg ranibizumab for a period limited to 24 months following administration of the first 2.0mg dose. Patients completing 36 months will be eligible to be followed for an additional 24 months. Starting at Month 36, patients will be able to receive monthly, the assigned dose that they received/or could have received(if re-treatment criteria was met)at Month 35. 2/1/12 - the 2.0mg dose has been discontinued, all subjects will transition to the 0.5mg dose.
| Study group | Role | What they receive |
|---|---|---|
| 0.5mg transitioning to 2.0mg | Active comparator | Ranibizumab-intravitreal injection Receives: Drug: ranibizumab |
| 1.0 mg transitioning to 2.0mg | Active comparator | Ranibizumab-intravitreal injection Receives: Drug: ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema
Measured: month 12
To compare the treatment of clinically significant diabetic macular edema with 0.5 mg of ranibizumab to 1.0 mg ranibizumab
Measured: month 12
Secondary outcomes (6)
Mean change in visual acuity as measured by ETDRS from baseline to month 12, 24 36,48 and 60 in each arm.
Measured: month 12, 24, 36, 48 and 60
Mean change in central retinal thickness on OCT from baseline to month 12, 24, 36, 48 and 60 in each arm
Measured: month 12, 24, 36,48 and 60
Changes observed on the fluorescein angiogram in each arm
Measured: Month 60
Mean number of ranibizumab injections required in each arm
Measured: Month 60
The need for "rescue therapy" with laser in each arm
Measured: Month 60
Evaluate the efficacy and safety of ranibizumab in the fellow eye in the sub-group of patients who require treatment for clinically significant diabetic macular edema in the fellow eye
Measured: Month 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startMar 2007
- Primary completionNov 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinically Significant Diabetic Macular EdemaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip J. ferrone, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Philip J. ferrone, M.D., Long Island Vitreoretinal Consultants
- Investigators
- Philip J. Ferrone, MD, Principal investigator, Long Island Vitreoretinal Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00440609
- Sponsor's protocol ID
- FVF3802s
- Status last verified
- Aug 2013
- First submitted
- 23 Feb 2007
- Last updated
- 2 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study Comparing the Treatment of Clinically Significant Diabetic Macular Edema (CSDME) With 0.5mg Ranibizumab, 1.0mg Ranibizumab and 2.0mg Ranibizumab
- ClinicalTrials.gov ID
- NCT00440609
- Acronym / sponsor ID
- FVF3802s
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Philip J. ferrone, M.D.University, hospital or other
- Study start
- Mar 2007
- Primary completion
- Nov 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 27 Feb 2007 (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 evaluate the safety and tolerability of Ranibizumab in patients with Clinically Significant Diabetic Macular Edema (CSDME). It will also compare treatment outcomes for patients receiving 0.5mg Ranibizumab and higher doses of 1.0mg and 2.0mg Ranibizumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5mg transitioning to 2.0mg | Active comparator | Drug: ranibizumabRanibizumab-intravitreal injection |
| 1.0 mg transitioning to 2.0mg | Active comparator | Drug: ranibizumabRanibizumab-intravitreal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type I or Type II diabetic subjects
- Vision between 20/20 and 20/400
- Presence of Clinically Significant Diabetic Macular Edema
Key exclusion criteria (12 listed)
- Presence of any condition that would prevent clear visualization of the back of the eye
- Uncontrolled glaucoma
- Complications of glaucoma
- Inflammation inside the eye
- Certain prior eye surgeries, other than cataract 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 |
|---|---|---|
| ranibizumab0.5mg or 1.0mg intravitreal injection given monthly for 3 months then every other month if needed, for the first year.Patients may be treated monthly as needed. Patients in Cohort 1(the first 30 patients)will be eligible to receive treatment as needed with 2.0mg ranibizumab starting at month 24. Patients in Cohort 2(the remaining 20)will be eligible to receive treatment as needed with 2.0mg ranibizumab starting at month 12.Patients may receive 2.0mg ranibizumab for a period limited to 24 months following administration of the first 2.0mg dose. Patients completing 36 months will be eligible to be followed for an additional 24 months. Starting at Month 36, patients will be able to receive monthly, the assigned dose that they received/or could have received(if re-treatment criteria was met)at Month 35. 2/1/12 - the 2.0mg dose has been discontinued, all subjects will transition to the 0.5mg dose. | Drug | 0.5mg transitioning to 2.0mg, 1.0 mg transitioning to 2.0mg |
Primary outcome
To evaluate safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema
Time frame: month 12
To compare the treatment of clinically significant diabetic macular edema with 0.5 mg of ranibizumab to 1.0 mg ranibizumab
Time frame: month 12
6 secondary outcomes
Mean change in visual acuity as measured by ETDRS from baseline to month 12, 24 36,48 and 60 in each arm.
Time frame: month 12, 24, 36, 48 and 60
Mean change in central retinal thickness on OCT from baseline to month 12, 24, 36, 48 and 60 in each arm
Time frame: month 12, 24, 36,48 and 60
Changes observed on the fluorescein angiogram in each arm
Time frame: Month 60
Mean number of ranibizumab injections required in each arm
Time frame: Month 60
The need for "rescue therapy" with laser in each arm
Time frame: Month 60
Evaluate the efficacy and safety of ranibizumab in the fellow eye in the sub-group of patients who require treatment for clinically significant diabetic macular edema in the fellow eye
Time frame: Month 60
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 2 Aug 2013.
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.
Philip J. Ferrone, MD principal investigator
Long Island Vitreoretinal Consultants
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ranibizumab in people with Clinically Significant Diabetic Macular Edema, run by Philip J. ferrone, M.D. at 2 sites 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 12 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 2 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
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?
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?
To evaluate safety and tolerability of ranibizumab in patients with clinically significant diabetic macular edema (time frame: month 12). 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 2 Aug 2013.