NCT01201161

Brief Summary

The purpose of this study was to assess the effect of ranibizumab in reducing intraoperative vitreous haemorrhage during pars plana vitrectomy, thus facilitating surgery and improving its anatomical and functional results in patients with advanced proliferative diabetic retinopathy and traction retinal detachment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_2

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

December 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2010

Completed
Last Updated

September 14, 2010

Status Verified

January 1, 2010

Enrollment Period

1.1 years

First QC Date

September 13, 2010

Last Update Submit

September 13, 2010

Conditions

Diabetic RetinopathyRetinal Detachment

Keywords

Diabetic RetinopathyRetinal detachmentVitreous HemorrhagePreoperative Ranibizumabpars plana vitrectomy

Outcome Measures

Primary Outcomes (1)

  • amount of intraoperative intra-ocular bleeding

    amount of intra-ocular bleeding that occurred during pars plana vitrectomy

    one week

Secondary Outcomes (1)

  • visual acuity

    12 weeks

Study Arms (2)

RANI/PPV

EXPERIMENTAL

Preoperative intravitreal ranibizumab and pars plana vitrectomy

Drug: Ranibizumab

PPV

PLACEBO COMPARATOR

Sham injection and pars plana vitrectomy

Other: Sham injection

Interventions

RanibizumabDRUG

Intravitreal injection of ranibizumab 0.05 ml (0.5 mg) one week before pars plana vitrectomy

Also known as: Lucentis
RANI/PPV
Sham injectionOTHER

Simulation of intravitreal injection one week before pars plana vitrectomy

PPV

Eligibility Criteria

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

You may qualify if:

  • Macular traction retinal detachment lasting three months or less secondary to diabetic retinopathy.

You may not qualify if:

  • Massive vitreous hemorrhage preventing from detailed posterior pole examination;
  • Previous intra-ocular surgery other than cataract surgery
  • Hemodialysis, known bleeding disorders or use of anticoagulants drugs other than aspirin
  • Prothrombin time, partial thromboplastin time or platelet count without normal limits
  • History of previous thromboembolic events

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of São Paulo

Ribeirão Preto, São Paulo, 14048-900, Brazil

Location

MeSH Terms

Conditions

Diabetic RetinopathyRetinal DetachmentVitreous Hemorrhage

Interventions

Ranibizumabsalicylhydroxamic acid

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Rodrigo Jorge, MD, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 14, 2010

Study Start

December 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

September 14, 2010

Record last verified: 2010-01

Locations

BR(1)