NCT01746563

Brief Summary

To evaluate the efficacy of combination therapy with ranibizumab (RBZ) and panretinal photocoagulation (PRP) versus PRP alone in patients with treatment-naive bilateral proliferative diabetic retinopathy (PDR) as measured by mean change in visual acuity (VA), mean change in central retinal thickness (CRT) as measured by time-domain optic coherence tomography (TD-OCT) and incidence of vitreous hemorrhage (VH).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2011

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

May 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 11, 2012

Completed
Last Updated

December 11, 2012

Status Verified

December 1, 2012

Enrollment Period

1.3 years

First QC Date

December 6, 2012

Last Update Submit

December 7, 2012

Conditions

Diabetic RetinopathyRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular Diseases

Keywords

Proliferative Diabetic RetinopathyRanibizumabPanretinal Photocoagulation

Outcome Measures

Primary Outcomes (1)

  • Macular Evaluation

    Changes between visual acuity from baseline to month 6.

    6 Months

Secondary Outcomes (1)

  • Structural Macular Evaluation

    06 months

Study Arms (2)

Ranibizumab

EXPERIMENTAL

Ranibizumab 0,05 mg intravitreal injection

Drug: RanibizumabProcedure: Laser therapy

Laser Therapy

ACTIVE COMPARATOR

Laser Therapy alone

Procedure: Laser therapy

Interventions

RanibizumabDRUG

Intravitreal injection

Also known as: Lucentis (Novartis)
Ranibizumab
Laser therapyPROCEDURE

Laser therapy

Laser TherapyRanibizumab

Eligibility Criteria

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

You may qualify if:

  • Naive Proliferative diabetic retinopathy eyes.
  • Best Corrected-Visual Acuity at baseline \> 20/320 in the study eye
  • Patients with and without diabetic macular edema
  • Type II diabetic subjects as defined by the World Health Organization aged ≥ 18 years.
  • Women must be using effective contraception
  • Ability to provide written informed consent.
  • Indication of panretinal photocoagulation in both eyes

You may not qualify if:

  • Vitreous hemorrhage or pre-retinal hemorrhage
  • Eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months
  • Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.
  • Cataract
  • Any intraocular surgery within 6 months before trial enrollment
  • Previous vitrectomy.
  • Any of the following underlying systemic diseases:
  • History or evidence of severe cardiac disease or previous thrombus-embolic event

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade of Sao Paulo

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (2)

  • Rentiya ZS, Ferraz DA, Hutnik R, Bae J, Machado CG, Mucciolli C, Motta AALD, Ribeiro LZ, Guan Z, Preti RC, Takahashi WY. Evaluation of contrast sensitivity in non-high-risk proliferative diabetic retinopathy treated with panretinal photocoagulation with and without intravitreal injections of ranibizumab. Arq Bras Oftalmol. 2022 Jan-Feb;85(1):37-45. doi: 10.5935/0004-2749.20220006.

    PMID: 34586227DERIVED

  • Ferraz DA, Vasquez LM, Preti RC, Motta A, Sophie R, Bittencourt MG, Sepah YJ, Monteiro ML, Nguyen QD, Takahashi WY. A randomized controlled trial of panretinal photocoagulation with and without intravitreal ranibizumab in treatment-naive eyes with non-high-risk proliferative diabetic retinopathy. Retina. 2015 Feb;35(2):280-7. doi: 10.1097/IAE.0000000000000363.

    PMID: 25272318DERIVED

MeSH Terms

Conditions

Diabetic RetinopathyRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular Diseases

Interventions

RanibizumablactitolLaser Therapy

Condition Hierarchy (Ancestors)

Diabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • Walter Y Takahashi, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmologist

Study Record Dates

First Submitted

December 6, 2012

First Posted

December 11, 2012

Study Start

May 1, 2011

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

December 11, 2012

Record last verified: 2012-12

Locations

BR(1)