NCT01102946

Brief Summary

The purpose of this study is to evaluate the effects of panretinal photocoagulation plus intravitreal ranibizumab for the treatment of patients with high risk proliferative diabetic retinopathy in terms of changes in visual acuity and neovascularization area.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

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

February 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 13, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

August 4, 2011

Status Verified

January 1, 2011

Enrollment Period

2 years

First QC Date

April 9, 2010

Last Update Submit

August 3, 2011

Conditions

Diabetic RetinopathyRetinal Neovascularization

Keywords

proliferative diabetic retinopathyretinal neovascularizationAngiogenesis Inhibitorsranibizumablaser

Outcome Measures

Primary Outcomes (1)

  • Fluorescein leakage area (mm2)

    Neovascularization area measured during fluorescein agiography middle phase

    Week 48 after inclusion in the study

Secondary Outcomes (4)

  • CMT

    Week 48 after inclusion in the study

  • LogMAR BCVA

    Week 48 after inclusion in the study

  • Retina mid periphery visual field sensitivity change

    Week 48 after inclusion in the study

  • Rod pathway integrity and oscillatory potential amplitudes

    Week 48 after inclusion in the study

Study Arms (2)

PRP plus ranibizumab

EXPERIMENTAL

Patients will be submitted to panretinal photocoagulation plus intravitreal injections of ranibizumab

Drug: RanibizumabProcedure: Panretinal Photocoagulation

PRP

ACTIVE COMPARATOR

Patients will only be submitted to panretinal photocoagulation

Procedure: Panretinal Photocoagulation

Interventions

RanibizumabDRUG

Ranibizumab (Lucentis), intravitreal injections of 0.05ml

Also known as: Lucentis
PRP plus ranibizumab
Panretinal PhotocoagulationPROCEDURE

Panretinal photocoagulation with green laser according to ETDRS

PRPPRP plus ranibizumab

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years old
  • High risk proliferative diabetic retinopathy
  • Visual acuity ≥ 20/800
  • No previous laser treatment for diabetic retinopathy

You may not qualify if:

  • Previous pars plana vitrectomy
  • Systemic thrombo-embolic events
  • Uncontrolled systemic hypertension
  • Conditions avoiding adequated documentation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

Related Links

MeSH Terms

Conditions

Diabetic RetinopathyRetinal Neovascularization

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 9, 2010

First Posted

April 13, 2010

Study Start

February 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

August 4, 2011

Record last verified: 2011-01

Locations

BR(1)