Recruiting
Phase 3

Ranibizumab

Sponsor:

Retina Associates, Kansas City

Code:

NCT00516464

Conditions

Proliferative Diabetic Retinopathy

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Lucentis (ranibizumab)

Study Details

Brief summary:

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

Conditions

Proliferative Diabetic Retinopathy

Study ID

NCT00516464

Start date

Aug, 2007

Status verified date

Aug, 2007

Completion date

Aug, 2008

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Lucentis (ranibizumab)

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Locations

Retina Associates, PA

Recruiting

Shawnee Mission, Kansas, United States, 66204

Contacts

Lexie Manning

913-831-7400lmanning@kcretina.com

Principal Investigator:

Gregory M Fox, MD

More Information

Sponsor

Retina Associates, Kansas City

Last update posted

Aug 15, 2007

Last verified

Aug, 2007

Keywords

  • Proliferative Diabetic Retinopathy
  • Vitrectomy
  • Ranibizumab

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by Retina Associates, Kansas City on 2007-08-15. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.