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Evaluation of Ranibizumab in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy

Primary Purpose

Proliferative Diabetic Retinopathy

Status

Unknown status

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Lucentis (ranibizumab)

About this trial

This is an interventional treatment trial for Proliferative Diabetic Retinopathy focused on measuring Proliferative Diabetic Retinopathy, Vitrectomy, Ranibizumab

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Ability to provide written informed consent and comply with study assessments for the full duration of the study
Age > 20 years
Best corrected visual acuity of 20/40 to 20/800 in the study eye
Very servere nonproliferative diabetic retinopathy (ETDRS level 53E) OR moderate proliferative diabetic retinopathy (ETDRS level 65)
Visual reduction attributable to diabetic vitreous hemorrhage or diabetic macular edema
Candidate for vitrectomy procedure

Exclusion Criteria:

Pregnancy (positive Pregnancy test) or lactation
Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
Participation in another simultaneous medical investigation or trial.
Visual impairment attributable to causes other than diabetic macular edema or diabetic vitreous hemorrhage.
Use of intraocular or periocular corticosteroids within 6 months.
History of panretinal photocoagulation
History of macular laser photocoagulation
History of pars plana vitrectomy
Prior or concomitant treatment with ranibizumab, bevacizumab, or pegaptanib sodium, either as part of an investigational study or as an off-label medication.
Current treatment of a systemic infection

Sites / Locations

Retina Associates, PARecruiting

Outcomes

Primary Outcome Measures

To evaluate the effect of ranibizumab on vitrectomy complications such as recurrent vitreous hemorrhage, postoperative retinal detachment rates, and development of intraoperative retinal breaks.

Secondary Outcome Measures

Full Information

NCT ID

NCT00516464

First Posted

August 14, 2007

Last Updated

August 14, 2007

Sponsor

Retina Associates, Kansas City

Collaborators

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00516464

Brief Title

Evaluation of Ranibizumab in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy

Official Title

Evaluation of Ranibizumab on the Ease of Procedure and Complication Rate in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy

Study Type

Interventional

2. Study Status

Record Verification Date

August 2007

Overall Recruitment Status

Unknown status

Study Start Date

August 2007 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

August 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Retina Associates, Kansas City

Collaborators

Genentech, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Evaluation of ranibizumab on the ease and procedure and complication in proliferative diabetic retinopathy (PDR) requiring vitrectomy.

Detailed Description

This is an open-label, Phase I/II study of multiple doses of intravitreally administered ranibizumab in patients with severe NPDR and PDR prior to, during, and after vitrectomy therapy. 40 subjects will be enrolled and randomized 3:1 to ranibizumab or vitrectomy alone. 30 consented, enrolled subjects will receive 3 intravitreal injections of 0.5 mg ranibizumab administered 1-3 weeks pre-procedure, intraoperatively, and 1 month post-vitrectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Proliferative Diabetic Retinopathy

Keywords

Proliferative Diabetic Retinopathy, Vitrectomy, Ranibizumab

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

Participant

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Lucentis (ranibizumab)

Primary Outcome Measure Information:

Title

To evaluate the effect of ranibizumab on vitrectomy complications such as recurrent vitreous hemorrhage, postoperative retinal detachment rates, and development of intraoperative retinal breaks.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study Age > 20 years Best corrected visual acuity of 20/40 to 20/800 in the study eye Very servere nonproliferative diabetic retinopathy (ETDRS level 53E) OR moderate proliferative diabetic retinopathy (ETDRS level 65) Visual reduction attributable to diabetic vitreous hemorrhage or diabetic macular edema Candidate for vitrectomy procedure Exclusion Criteria: Pregnancy (positive Pregnancy test) or lactation Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch. Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated. Participation in another simultaneous medical investigation or trial. Visual impairment attributable to causes other than diabetic macular edema or diabetic vitreous hemorrhage. Use of intraocular or periocular corticosteroids within 6 months. History of panretinal photocoagulation History of macular laser photocoagulation History of pars plana vitrectomy Prior or concomitant treatment with ranibizumab, bevacizumab, or pegaptanib sodium, either as part of an investigational study or as an off-label medication. Current treatment of a systemic infection

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gregory M Fox, MD

Organizational Affiliation

Retina Associates, PA

Official's Role

Principal Investigator

Facility Information:

Facility Name

Retina Associates, PA

City

Shawnee Mission

State/Province

Kansas

ZIP/Postal Code

66204

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lexie Manning

Phone

913-831-7400

lmanning@kcretina.com

First Name & Middle Initial & Last Name & Degree

Gregory M Fox, MD

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Ranibizumab in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy

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