Evaluation of Ranibizumab in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Retina Associates, Kansas City.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Retina Associates, Kansas City
Collaborator:
Genentech, Inc.
Information provided by:
Retina Associates, Kansas City
ClinicalTrials.gov Identifier:
NCT00516464
First received: August 14, 2007
Last updated: NA
Last verified: August 2007
History: No changes posted
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Purpose
Evaluation of ranibizumab on the ease and procedure and complication in proliferative diabetic retinopathy (PDR) requiring vitrectomy.
| Condition | Intervention | Phase |
|---|---|---|
|
Proliferative Diabetic Retinopathy |
Drug: Lucentis (ranibizumab) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment |
| Official Title: | Evaluation of Ranibizumab on the Ease of Procedure and Complication Rate in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy |
Resource links provided by NLM:
Further study details as provided by Retina Associates, Kansas City:
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. [ Time Frame: 6 months ]
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2007 |
| Estimated Study Completion Date: | August 2008 |
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.
Eligibility| Ages Eligible for Study: | 21 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516464
Please refer to this study by its ClinicalTrials.gov identifier: NCT00516464
Locations
| United States, Kansas | |
| Retina Associates, PA | Recruiting |
| Shawnee Mission, Kansas, United States, 66204 | |
| Contact: Lexie Manning 913-831-7400 lmanning@kcretina.com | |
| Principal Investigator: Gregory M Fox, MD | |
Sponsors and Collaborators
Retina Associates, Kansas City
Genentech, Inc.
Investigators
| Principal Investigator: | Gregory M Fox, MD | Retina Associates, PA |
More Information
| ClinicalTrials.gov Identifier: | NCT00516464 History of Changes |
| Other Study ID Numbers: | FVF4295 |
| Study First Received: | August 14, 2007 |
| Last Updated: | August 14, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Retina Associates, Kansas City:
|
Proliferative Diabetic Retinopathy Vitrectomy Ranibizumab |
Additional relevant MeSH terms:
|
Retinal Diseases Diabetic Retinopathy Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
Ranibizumab Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on September 30, 2016