Diabetic Macular EdemaPhase 4OPTIMALNCT01297569
Ranibizumab "Treat and Extend" in Diabetic Macular Edma
A Phase 4 study testing Ranibizumab in people with Diabetic Macular Edema, run by Novartis Pharmaceuticals at 1 site in Norway.
Trial summary
This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema. Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Ranibizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2011to Nov 2012
- Phase
- Phase 4
- 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 to 18 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Visual impairment due to focal or diffuse macular edema with center involvement
- Diabetes type 1 or 2, HbA1c < 12.0%
- CRT = or > 250 μm
Who cannot join
- Active inflammation or infection
- Uncontrolled glaucoma
- Iris neovascularization, active proliferative retinopathy or vitreomacular traction
- Prior laser photocoagulation according to defined timelines
- History of stroke, uncontrolled hypertension
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Prospective, Multicentre, Uncontrolled, Proof of Concept Study Assessing the Efficacy of Lucentis (Ranibizumab) Administered by an Individualized "Treat and Extend" Dosing Regimen in Patients With Visual Impairment Due to Diabetic Macular Edema
This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema.
- Conditions
- Diabetic Macular Edema
- Being tested
- Ranibizumab
- Keywords
- Diabetic macular edema, Macular edema, DME, Diabetic retinopathy, Diabetic eye disease, anti-VEGF, ranibizumab, Lucentis
- Medical subject headings
- Macular Edema, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab | Experimental | Not described Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Best Corrected Visual Acuity(BCVA)
Measured: from month 0 (baseline) to month 12
Secondary outcomes (4)
change in central retinal thickness (CRT)
Measured: from month 0 to month 12
the number of injections needed
Measured: 12 months
the number of patients with improvement in BCVA from baseline
Measured: 12 months
the number of patients with > 5, 10 and 15 letters improvement from baseline, the latter including patients reaching BCVA >84
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 posted16 Feb 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01297569
- Sponsor's protocol ID
- CRFB002DNO02
- Other IDs
- 2010-021182-76
- Acronym
- OPTIMAL
- Status last verified
- Feb 2017
- First submitted
- 15 Feb 2011
- Last updated
- 23 Feb 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Prospective, Multicentre, Uncontrolled, Proof of Concept Study Assessing the Efficacy of Lucentis (Ranibizumab) Administered by an Individualized "Treat and Extend" Dosing Regimen in Patients With Visual Impairment Due to Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT01297569
- Acronym / sponsor ID
- OPTIMAL / CRFB002DNO02
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic macular edema, Macular edema, DME, Diabetic retinopathy, Diabetic eye disease, anti-VEGF, ranibizumab, Lucentis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 16 Feb 2011 (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.
This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab | Experimental | Drug: Ranibizumab |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Visual impairment due to focal or diffuse macular edema with center involvement
- Diabetes type 1 or 2, HbA1c < 12.0%
- CRT = or > 250 μm
Key exclusion criteria (6 listed)
- Active inflammation or infection
- Uncontrolled glaucoma
- Iris neovascularization, active proliferative retinopathy or vitreomacular traction
- Prior laser photocoagulation according to defined timelines
- History of stroke, uncontrolled hypertension
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 | Drug | Ranibizumab |
Primary outcome
Change in Best Corrected Visual Acuity(BCVA)
Time frame: from month 0 (baseline) to month 12
4 secondary outcomes
change in central retinal thickness (CRT)
Time frame: from month 0 to month 12
the number of injections needed
Time frame: 12 months
the number of patients with improvement in BCVA from baseline
Time frame: 12 months
the number of patients with > 5, 10 and 15 letters improvement from baseline, the latter including patients reaching BCVA >84
Time frame: 12 months
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 23 Feb 2017.
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Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ranibizumab in people with Diabetic Macular Edema, run by Novartis Pharmaceuticals at 1 site in Norway.
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 6 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 23 Feb 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 Norway. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in Best Corrected Visual Acuity(BCVA) (time frame: from month 0 (baseline) to month 12). 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 23 Feb 2017.