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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Especialistas en Retina Medica y Quirurgica Grupo de Investigacion.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Fundación Mexicana de Retina
Information provided by:
Especialistas en Retina Medica y Quirurgica Grupo de Investigacion
ClinicalTrials.gov Identifier:
NCT01112085
First received: April 23, 2010
Last updated: June 14, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Diabetic Macular Edema
Drug: Ranibizumab 0.05mg
Drug: Ranibizumab 0.5mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Phase 2 Study of Microdoses of Ranibizumab in Diabetic Macular Edema - the MINIMA 2 Study

Resource links provided by NLM:


Further study details as provided by Especialistas en Retina Medica y Quirurgica Grupo de Investigacion:

Primary Outcome Measures:
  • Best corrected visual acuity [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months and 12 months ] [ Designated as safety issue: Yes ]
    Changes in central retinal thickness and volume assessed by optical coherence tomography (OCT)


Estimated Enrollment: 72
Study Start Date: April 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab 0.05mg
Intravitreal 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
Intravitreal injections of 0.05mg ranibizumab over 6 months then additional treatment with ranibizumab 0.05mg as needed (according to re-treatment criteria)
Experimental: Ranibizumab 0.5mg
Intravitreal 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
Intravitreal injections of 0.5mg ranibizumab over 6 months then additional treatment with ranibizumab 0.5mg as needed (according to re-treatment criteria)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112085

Locations
Argentina
Centro Privado de Ojos Rogamosa SA y Fundación VER
Córdoba, Argentina
Mexico
Hospital San José
Guadalajara, Jalisco, Mexico, 44600
Hospital Regional Valentín Gómez Farías
Zapopan, Jalisco, Mexico, 45100
Centro de Retina Médica y Quirúrgica S. C.
Zapopan, Jalisco, Mexico, 44116
Hospital Universitario Doctor José Eleuterio González
Monterrey, Nuevo León, Mexico, 64460
Hospital Central
San Luis Potosí, Mexico, 78250
Sponsors and Collaborators
Especialistas en Retina Medica y Quirurgica Grupo de Investigacion
Fundación Mexicana de Retina
Investigators
Principal Investigator: Arturo Santos, MD PhD Centro de Retina Médica y Quirúrgica S. C.
  More Information

No publications provided

Responsible Party: Fundación Mexicana de Retina
ClinicalTrials.gov Identifier: NCT01112085     History of Changes
Other Study ID Numbers: MINIMA-2
Study First Received: April 23, 2010
Last Updated: June 14, 2011
Health Authority: Mexico: Ethics Committee

Keywords provided by Especialistas en Retina Medica y Quirurgica Grupo de Investigacion:
Diabetic macular edema
Ranibizumab

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014