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

NCT00516464 | Unknown Phase 3

• 1 other identifier: FVF4295
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Proliferative Diabetic Retinopathy

Keywords

Proliferative Diabetic Retinopathy; Vitrectomy; Ranibizumab

Outcome Measures

Primary Outcomes (1)

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

  6 months

Interventions

Lucentis (ranibizumab) DRUG

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Retina Associates, Kansas City: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Retina Associates, PA

Shawnee Mission, Kansas, 66204, United States

RECRUITING

Related Publications (1)

• Dervenis P, Dervenis N, Smith JM, Steel DH. Anti-vascular endothelial growth factors in combination with vitrectomy for complications of proliferative diabetic retinopathy. Cochrane Database Syst Rev. 2023 May 31;5(5):CD008214. doi: 10.1002/14651858.CD008214.pub4.

  PMID: 37260074 DERIVED

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Gregory M Fox, MD

  Retina Associates, PA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 14, 2007
• First Posted: August 15, 2007
• Study Start: August 1, 2007
• Study Completion: August 1, 2008
• Last Updated: August 15, 2007

Record last verified: 2007-08

Locations

US (1)