Diabetic Macular EdemaPhase 2MINIMA-2NCT01112085
MIcrodoses of raNIbizumab in Diabetic MAcular Edema (MINIMA-2)
A Phase 2 study testing Ranibizumab 0.05mg and Ranibizumab 0.5mg in people with Diabetic Macular Edema, run by Especialistas en Retina Medica y Quirurgica Grupo de Investigacion at 6 sites in 2 countries.
Trial summary
The objective of this study is to investigate if the drug ranibizumab administrated by microdose injection into the eye is safe and effective to treat diabetic macular edema. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Ranibizumab 0.05mg and Ranibizumab 0.5mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Apr 2010to Jun 2014
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, 18 years of age or older
- Subjects with diagnosis of diabetes mellitus (Type I or II)
- Signed informed consent
- Patient must be able to comply with study assessments
- Clinical sings and angiographic evidence of diabetic macular edema
- Central foveal thickness of at least 270 assessed by OCT
- Best corrected visual acuity of 20/40 to 20/320 (ETDRS chart) in the study eye
Who cannot join
- Patients who do not fulfill the inclusion criteria
- Use of any intraocular or periocular drug injection over the previous 3 months
- Macular or panretinal photocoagulation within 3 months of the study entry in the study eye
- High myopia (more than 6D)
- Any ocular disorders in the study eye that may confound interpretation of study results including patients with choroidal neovascularization, macular hole, retinal detachment, epiretinal membrane, ischemic maculopathy or any other retinal vascular disease such as vascular occlusive diseases.
- Vitreomacular traction
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- Subretinal fibrosis
- Uncontrolled or advanced glaucoma
- Active ocular inflammation or history of active intraocular inflammation during the 6 months prior to enrollment of the study
- Any ophthalmic surgery performed within 3 months prior to study entry in the study eye
- Previous pars plana vitrectomy in the study eye
- History of ocular trauma of any type in the study eye
- Subjects with media opacities or abnormalities that would preclude observation of the retina in the study eye, per the investigator's judgement
- History of fluorescein allergy
- Known hypersensitivity to ranibizumab
- History of stroke or Myocardial infraction within 6 months
- Pregnancy, lactation or any women with no adequate contraception
- Participation in another simultaneous medical investigation or trial
- Any other condition that, in the opinion of the investigator, would produce a significant hazard or jeopardize the safety of the patient
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Mexico5 sites
Hospital San José
Guadalajara, Jalisco, 44600
Hospital Universitario Doctor José Eleuterio González
Monterrey, Nuevo León, 64460
Hospital Central
San Luis Potosí City, San Luis Potosí, 78250
Centro de Retina Médica y Quirúrgica S. C.
Zapopan, Jalisco, 44116
Hospital Regional Valentín Gómez Farías
Zapopan, Jalisco, 45100
About this study
Official title: Phase 2 Study of Microdoses of Ranibizumab in Diabetic Macular Edema - the MINIMA 2 Study
The objective of this study is to investigate if the drug ranibizumab administrated by microdose injection into the eye is safe and effective to treat diabetic macular edema.
Read the detailed description
The MINIMA-2 Study is a multi-center clinical trial that initiated in order to investigate the effect of microdoses of ranibizumab in diabetic macular edema. The duration of the study is up to 13 months. Patients with diabetic macular edema will be randomized into 2 different groups. Consented subjects will receive monthly injections over a 6-month treatment period, and a 6 month follow-up and treatment period. Several eye examinations and procedures will be performed to evaluate response to the treatment. These include best corrected visual acuity testing (ETDRS), contrast sensitivity testing, ophthalmic examination, fluorescein angiography (FA)and macular thickness measurements based on optical coherence tomography (OCT). Serum chemistry, hematology and glycosylated hemoglobin HbA1c testing, urinalysis and pregnancy testing will be performed at screening visit (Days -14 to 0) and two more times during the study.
Approximately 72 patients with a baseline central foveal thickness by OCT of at least 270 will be included. The BCVA must be worst than 20/40 but better than or equal to 20/320 due diabetic macular edema.
- Conditions
- Diabetic Macular Edema
- Being tested
- Ranibizumab 0.05mg, Ranibizumab 0.5mg
- Keywords
- Diabetic macular edema, Ranibizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ranibizumab 0.05mgDrug
Intravitreal injections of 0.05mg ranibizumab over 6 months then additional treatment with ranibizumab 0.05mg as needed (according to re-treatment criteria)
Ranibizumab 0.5mgDrug
Intravitreal injections of 0.5mg ranibizumab over 6 months then additional treatment with ranibizumab 0.5mg as needed (according to re-treatment criteria)
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab 0.05mg | Experimental | Intravitreal injections of 0.05mg ranibizumab over 6 months then additional treatment with ranibizumab 0.05mg as needed (according to re-treatment criteria) Receives: Drug: Ranibizumab 0.05mg |
| Ranibizumab 0.5mg | Experimental | Intravitreal injections of 0.5mg ranibizumab over 6 months then additional treatment with ranibizumab 0.5mg as needed (according to re-treatment criteria) Receives: Drug: Ranibizumab 0.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Improvement in vision of best corrected visual acuity of 15 or more letters, or a final vision of 20/25 (50 letters) or better if best corrected visual acuity (BCVA) was 20/40 (40 letters)
Measured: 12 months
Secondary outcomes (1)
Mean change in central retinal thickness and volume by OCT
Changes in central retinal thickness and volume assessed by optical coherence tomography (OCT)
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2014
- Study completionJun 2014
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.
- 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
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Especialistas en Retina Medica y Quirurgica Grupo de Investigacion
- Sponsor type
- Research network
- Collaborators
- Centro de Retina Medica y Quirurgica S.C.
- Responsible party
- Sponsor
- Investigators
- Arturo Santos, MD PhD, Principal investigator, Centro de Retina Médica y Quirúrgica S.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112085
- Sponsor's protocol ID
- MINIMA-2
- Acronym
- MINIMA-2
- Status last verified
- Jun 2014
- First submitted
- 23 Apr 2010
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Microdoses of Ranibizumab in Diabetic Macular Edema - the MINIMA 2 Study
- ClinicalTrials.gov ID
- NCT01112085
- Acronym / sponsor ID
- MINIMA-2 / MINIMA-2
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic macular edema, Ranibizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Especialistas en Retina Medica y Quirurgica Grupo de InvestigacionResearch network
- Collaborators
- Centro de Retina Medica y Quirurgica S.C.
- Study start
- Apr 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 28 Apr 2010 (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 objective of this study is to investigate if the drug ranibizumab administrated by microdose injection into the eye is safe and effective to treat diabetic macular edema.
Detailed description
The MINIMA-2 Study is a multi-center clinical trial that initiated in order to investigate the effect of microdoses of ranibizumab in diabetic macular edema. The duration of the study is up to 13 months. Patients with diabetic macular edema will be randomized into 2 different groups. Consented subjects will receive monthly injections over a 6-month treatment period, and a 6 month follow-up and treatment period. Several eye examinations and procedures will be performed to evaluate response to the treatment. These include best corrected visual acuity testing (ETDRS), contrast sensitivity testing, ophthalmic examination, fluorescein angiography (FA)and macular thickness measurements based on optical coherence tomography (OCT). Serum chemistry, hematology and glycosylated hemoglobin HbA1c testing, urinalysis and pregnancy testing will be performed at screening visit (Days -14 to 0) and two more times during the study.
Approximately 72 patients with a baseline central foveal thickness by OCT of at least 270 will be included. The BCVA must be worst than 20/40 but better than or equal to 20/320 due diabetic macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab 0.05mg | Experimental | Drug: Ranibizumab 0.05mgIntravitreal injections of 0.05mg ranibizumab over 6 months then additional treatment with ranibizumab 0.05mg as needed (according to re-treatment criteria) |
| Ranibizumab 0.5mg | Experimental | Drug: Ranibizumab 0.5mgIntravitreal injections of 0.5mg ranibizumab over 6 months then additional treatment with ranibizumab 0.5mg as needed (according to re-treatment criteria) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects, 18 years of age or older
- Subjects with diagnosis of diabetes mellitus (Type I or II)
- Signed informed consent
- Patient must be able to comply with study assessments
- Clinical sings and angiographic evidence of diabetic macular edema
Key exclusion criteria (19 listed)
- Patients who do not fulfill the inclusion criteria
- Use of any intraocular or periocular drug injection over the previous 3 months
- Macular or panretinal photocoagulation within 3 months of the study entry in the study eye
- High myopia (more than 6D)
- Any ocular disorders in the study eye that may confound interpretation of study results including patients with choroidal neovascularization, macular hole, retinal detachment, epiretinal membrane, ischemic maculopathy or any other retinal vascular disease such as vascular occlusive diseases.
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 0.05mgIntravitreal injections of 0.05mg ranibizumab over 6 months then additional treatment with ranibizumab 0.05mg as needed (according to re-treatment criteria) | Drug | Ranibizumab 0.05mg |
| Ranibizumab 0.5mgIntravitreal injections of 0.5mg ranibizumab over 6 months then additional treatment with ranibizumab 0.5mg as needed (according to re-treatment criteria) | Drug | Ranibizumab 0.5mg |
Primary outcome
Best corrected visual acuity
Time frame: 12 months
Improvement in vision of best corrected visual acuity of 15 or more letters, or a final vision of 20/25 (50 letters) or better if best corrected visual acuity (BCVA) was 20/40 (40 letters)
1 secondary outcome
Mean change in central retinal thickness and volume by OCT
Time frame: 6 months and 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 16 Jun 2014.
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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.
Arturo Santos, MD PhD principal investigator
Centro de Retina Médica y Quirúrgica S.C.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ranibizumab 0.05mg and Ranibizumab 0.5mg in people with Diabetic Macular Edema, run by Especialistas en Retina Medica y Quirurgica Grupo de Investigacion at 6 sites in 2 countries.
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 19 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 16 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Mexico, Argentina. 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?
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?
Best corrected visual acuity (time frame: 12 months). 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 16 Jun 2014.