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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Especialistas en Retina Medica y Quirurgica Grupo de Investigacion
• Collaborator: Centro de Retina Medica y Quirúrgica S.C.
• Treatments: Ranibizumab

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