NCT01112085

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2010

Typical duration for phase_2

Geographic Reach
2 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

June 16, 2014

Status Verified

June 1, 2014

Enrollment Period

3.8 years

First QC Date

April 23, 2010

Last Update Submit

June 13, 2014

Conditions

Diabetic Macular Edema

Keywords

Diabetic macular edemaRanibizumab

Outcome Measures

Primary Outcomes (1)

  • 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)

    12 months

Secondary Outcomes (1)

  • Mean change in central retinal thickness and volume by OCT

    6 months and 12 months

Study Arms (2)

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)

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)

Drug: Ranibizumab 0.5mg

Interventions

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 0.05mg
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)

Ranibizumab 0.5mg

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Centro Privado de Ojos Rogamosa SA y Fundación VER

Córdoba, Argentina

Location

Hospital San José

Guadalajara, Jalisco, 44600, Mexico

Location

Centro de Retina Médica y Quirúrgica S. C.

Zapopan, Jalisco, 44116, Mexico

Location

Hospital Regional Valentín Gómez Farías

Zapopan, Jalisco, 45100, Mexico

Location

Hospital Universitario Doctor José Eleuterio González

Monterrey, Nuevo León, 64460, Mexico

Location

Hospital Central

San Luis Potosí City, San Luis Potosí, 78250, Mexico

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Arturo Santos, MD PhD

    Centro de Retina Médica y Quirúrgica S. C.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2010

First Posted

April 28, 2010

Study Start

April 1, 2010

Primary Completion

January 1, 2014

Study Completion

June 1, 2014

Last Updated

June 16, 2014

Record last verified: 2014-06

Locations

AR(1)ME(5)