Evaluation of Ranibizumab in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00516464 |
Recruitment Status : Unknown
Verified August 2007 by Retina Associates, Kansas City.
Recruitment status was: Recruiting
First Posted : August 15, 2007
Last Update Posted : August 15, 2007
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Proliferative Diabetic Retinopathy | Drug: Lucentis (ranibizumab) | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Evaluation of Ranibizumab on the Ease of Procedure and Complication Rate in Proliferative Diabetic Retinopathy (PDR) Requiring Vitrectomy |
Study Start Date : | August 2007 |
Estimated Study Completion Date : | August 2008 |

- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516464
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 |
Principal Investigator: | Gregory M Fox, MD | Retina Associates, PA |
ClinicalTrials.gov Identifier: | NCT00516464 |
Other Study ID Numbers: |
FVF4295 |
First Posted: | August 15, 2007 Key Record Dates |
Last Update Posted: | August 15, 2007 |
Last Verified: | August 2007 |
Proliferative Diabetic Retinopathy Vitrectomy Ranibizumab |
Retinal Diseases Diabetic Retinopathy Eye Diseases Diabetic Angiopathies Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus |
Endocrine System Diseases Ranibizumab Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |