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MIcrodoses of raNIbizumab in Diabetic MAcular Edema (MINIMA-2) (MINIMA-2)

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ranibizumab 0.05mg
Ranibizumab 0.5mg
Sponsored by
Especialistas en Retina Medica y Quirurgica Grupo de Investigacion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic macular edema, Ranibizumab

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Centro Privado de Ojos Rogamosa SA y Fundación VER
  • Hospital San José
  • Centro de Retina Médica y Quirúrgica S. C.
  • Hospital Regional Valentín Gómez Farías
  • Hospital Universitario Doctor José Eleuterio González
  • Hospital Central

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ranibizumab 0.05mg

Ranibizumab 0.5mg

Arm Description

Intravitreal injections of 0.05mg ranibizumab over 6 months then additional treatment with ranibizumab 0.05mg as needed (according to re-treatment criteria)

Intravitreal injections of 0.5mg ranibizumab over 6 months then additional treatment with ranibizumab 0.5mg as needed (according to re-treatment criteria)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Mean change in central retinal thickness and volume by OCT
Changes in central retinal thickness and volume assessed by optical coherence tomography (OCT)

Full Information

First Posted
April 23, 2010
Last Updated
June 13, 2014
Sponsor
Especialistas en Retina Medica y Quirurgica Grupo de Investigacion
Collaborators
Centro de Retina Medica y Quirurgica S.C.
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1. Study Identification

Unique Protocol Identification Number
NCT01112085
Brief Title
MIcrodoses of raNIbizumab in Diabetic MAcular Edema (MINIMA-2)
Acronym
MINIMA-2
Official Title
Phase 2 Study of Microdoses of Ranibizumab in Diabetic Macular Edema - the MINIMA 2 Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Especialistas en Retina Medica y Quirurgica Grupo de Investigacion
Collaborators
Centro de Retina Medica y Quirurgica S.C.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Diabetic macular edema, Ranibizumab

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranibizumab 0.05mg
Arm Type
Experimental
Arm Description
Intravitreal injections of 0.05mg ranibizumab over 6 months then additional treatment with ranibizumab 0.05mg as needed (according to re-treatment criteria)
Arm Title
Ranibizumab 0.5mg
Arm Type
Experimental
Arm Description
Intravitreal injections of 0.5mg ranibizumab over 6 months then additional treatment with ranibizumab 0.5mg as needed (according to re-treatment criteria)
Intervention Type
Drug
Intervention Name(s)
Ranibizumab 0.05mg
Intervention Description
Intravitreal injections of 0.05mg ranibizumab over 6 months then additional treatment with ranibizumab 0.05mg as needed (according to re-treatment criteria)
Intervention Type
Drug
Intervention Name(s)
Ranibizumab 0.5mg
Intervention Description
Intravitreal injections of 0.5mg ranibizumab over 6 months then additional treatment with ranibizumab 0.5mg as needed (according to re-treatment criteria)
Primary Outcome Measure Information:
Title
Best corrected visual acuity
Description
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)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Mean change in central retinal thickness and volume by OCT
Description
Changes in central retinal thickness and volume assessed by optical coherence tomography (OCT)
Time Frame
6 months and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arturo Santos, MD PhD
Organizational Affiliation
Centro de Retina Médica y Quirúrgica S. C.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Privado de Ojos Rogamosa SA y Fundación VER
City
Córdoba
Country
Argentina
Facility Name
Hospital San José
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Centro de Retina Médica y Quirúrgica S. C.
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
44116
Country
Mexico
Facility Name
Hospital Regional Valentín Gómez Farías
City
Zapopan
State/Province
Jalisco
ZIP/Postal Code
45100
Country
Mexico
Facility Name
Hospital Universitario Doctor José Eleuterio González
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Hospital Central
City
San Luis Potosí
ZIP/Postal Code
78250
Country
Mexico

12. IPD Sharing Statement

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MIcrodoses of raNIbizumab in Diabetic MAcular Edema (MINIMA-2)

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