NCT01280929

Brief Summary

The purpose of this trial is to evaluate safety and to compare the efficacy of intravitreous injection of ranibizumab alone (0.5 mg), versus combination of intravitreous injection of ranibizumab (0.5 mg) plus panretinal photocoagulation, versus panretinal photocoagulation alone in the regression of retinal neovascularization in eyes with high-risk proliferative diabetic retinopathy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2010

Typical duration for phase_2

Geographic Reach
1 country

7 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

September 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 21, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

October 8, 2015

Status Verified

October 1, 2015

Enrollment Period

3.3 years

First QC Date

January 20, 2011

Last Update Submit

October 7, 2015

Conditions

High Risk Proliferative Diabetic Retinopathy

Keywords

High Risk Proliferative Diabetic RetinopathyRanibizumabPanretinal Photocoagulation

Outcome Measures

Primary Outcomes (1)

  • Regression of neovascularization

    To demonstrate superiority of one of the treatment arms: ranibizumab 0.5 mg monotherapy, panretinal photocoagulation monotherapy or combination therapy (ranibizumab 0.5 mg plus panretinal photocoagulation) over a 12-month treatment period in the regression of neovascularization.

    12-month treatment

Secondary Outcomes (7)

  • Changes from baseline in Best-Corrected Visual Acuity

    12-month treatment

  • Changes from baseline in macular retinal thickness by Optical Coherent Tomography

    12-month treatment

  • Recurrence of neovascularization

    12-month treatment

  • Number of treatments needed

    12-month treatment

  • Additional focal or grid laser for Diabetic Macular Edema

    12 month treatment

  • +2 more secondary outcomes

Study Arms (3)

Panretinal Photocoagulation (PRP)

ACTIVE COMPARATOR

Group 1: Panretinal photocoagulation treatment (PRP) at month-0 that can be repeated after month-3.

Procedure: Panretinal Photocoagulation (PRP)

Ranibizumab

EXPERIMENTAL

Group 2: Intravitreous injections of ranibizumab every 4 weeks at month-0, month-1 and month-2 that can be repeated after month-3.

Drug: Intravitreous injection of ranibizumab

Ranibizumab + Panretinal Photocoagulation (PRP)

EXPERIMENTAL

Group 3: Combination treatment of ranibizumab intravitreous injections plus PRP (2 weeks +/- 1 week after injection), at month-0, month-1 and month-2 that can be repeated after month-3.

Procedure: Panretinal Photocoagulation (PRP)Drug: Intravitreous injection of ranibizumab

Interventions

Panretinal Photocoagulation (PRP)PROCEDURE
Panretinal Photocoagulation (PRP)Ranibizumab + Panretinal Photocoagulation (PRP)
Intravitreous injection of ranibizumabDRUG
RanibizumabRanibizumab + Panretinal Photocoagulation (PRP)

Eligibility Criteria

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

You may qualify if:

  • High-risk proliferative diabetic retinopathy (HR-PDR) eyes.
  • Best Corrected-Visual Acuity at baseline \> 20/320 in the study eye.
  • Clear ocular media and adequate pupillary dilatation to permit good quality fundus photography.
  • Intraocular pressure \< 21 mmHg.
  • Type I, or Type II diabetic subjects as defined by the World Health Organization criteria of either gender, and aged ≥ 18 years.
  • Women must be using effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile.
  • Ability to provide written informed consent.
  • Ability to return for all trial visits.

You may not qualify if:

  • Eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months.
  • Fibrovascular proliferation with retinal traction.
  • Other cause of retinal neovascularization (retinal vein occlusion, radiation retinopathy or others).
  • Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.
  • Subjects who have received yttrium-aluminum-garnet laser, or peripheral retinal cryoablation, or laser retinopexy (for retinal tears only), or focal/grid photocoagulation, within the previous 6 months.
  • Significant media opacities, which might interfere with visual acuity, assessment of toxicity or fundus photography.
  • Subjects should not be entered if there is likelihood that they will require cataract surgery within the following 1 year.
  • Any intraocular surgery within 6 months before trial enrollment.
  • Previous vitrectomy.
  • HbA1C level \>11% or recent signs of uncontrolled diabetes.
  • Any of the following underlying systemic diseases:
  • History or evidence of severe cardiac disease.
  • History or evidence of clinically significant peripheral vascular disease such as intermittent claudication or prior amputation.
  • Clinically significant impaired renal function (serum creatinine \>2.5 mg/dL or s/p renal transplant or receiving dialysis).
  • Clinically significant impaired hepatic function.
  • +13 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image

Coimbra, 3000-548, Portugal

Location

Espaço Médico de Coimbra

Coimbra, 3030-163, Portugal

Location

ALM Oftalmolaser

Lisbon, 1050-078, Portugal

Location

Instituto de Retina de Lisboa

Lisbon, 1050-085, Portugal

Location

Instituto de Oftalmologia Dr. Gama Pinto

Lisbon, 1169-019, Portugal

Location

Instituto CUF

Porto, 4100-180, Portugal

Location

Hospital de São João

Porto, 4200-319, Portugal

Location

Related Publications (1)

  • Figueira J, Silva R, Henriques J, Caldeira Rosa P, Lains I, Melo P, Goncalves Nunes S, Cunha-Vaz J. Ranibizumab for High-Risk Proliferative Diabetic Retinopathy: An Exploratory Randomized Controlled Trial. Ophthalmologica. 2016;235(1):34-41. doi: 10.1159/000442026. Epub 2015 Dec 3.

    PMID: 26630400DERIVED

Study Officials

  • José Cunha-Vaz, MD, PhD

    Association for Innovation and Biomedical Research on Light and Image

    STUDY CHAIR

  • João Figueira, MD

    Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Investigator Coordinator

Study Record Dates

First Submitted

January 20, 2011

First Posted

January 21, 2011

Study Start

September 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

October 8, 2015

Record last verified: 2015-10

Locations

PT(7)