Use of Intravitreal Ranibizumab in the Treatment of Vitreous Hemorrhage

NCT01824043 | Unknown Phase 4

• 1 other identifier: LUBRAHV
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objective: To investigate the effectiveness of intravitreal applications of 0.5 mg Lucentis (ranibizumab) in patients with vitreous hemorrhage due to proliferative diabetic retinopathy. The primary endpoint for the study will be the mean change in best-corrected visual acuity (BCVA) from baseline to the mean level at Month 3. Secondary Objectives:

1. 1.To assess any differences in mean change in BCVA over time;
2. 2.To assess differences in vitreous transparency (amount of hemorrhage) with fundus angiography exam;
3. 3.To assess any differences in retinopathy severity level according to the Early Treatment Diabetic Retinopathy Study;
4. 4.To correlate the visual outcomes with serum glucose levels.

Conditions

Diabetic Retinopathy; Vitreous Hemorrhage

Keywords

diabetic retinopathy; vitreous hemorrhage; intravitreal ranibizumab

Outcome Measures

Primary Outcomes (1)

• Gain in visual acuity and transparence of vitreous in treated eyes.

  90 days

Other Outcomes (3)

• Visual acuity improvement measured by Snellen chart

  90 days

• Reduction in the ETDRS diabetic retinopathy severity level

  90 days

• Serum glucose levels will be compared with the visual outcomes

  90 days

Study Arms (1)

vitreous hemorrhage group

EXPERIMENTAL

Patients will be treated monthly: intravitreal ranibizumab (0.5 mg) will be administered in an open-label fashion, using 3 monthly injections (at day 0, day 30 and day 60) followed by an additional post treatment visit, a month after the last injection, for posterior reports

Drug: intravitreal ranibizumab injections

Interventions

intravitreal ranibizumab injections DRUG

Patients will be treated monthly: intravitreal ranibizumab (0.5 mg) will be administered in an open-label fashion, using 3 monthly injections (at day 0, day 30 and day 60) followed by an additional post treatment visit, a month after the last injection, for posterior reports

vitreous hemorrhage group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients \>18 years of age who have signed an informed consent
• Patients with Type 1 or Type 2 diabetes mellitus (according to ADA or WHO guidelines).
• Patients with visual impairment due to vitreous hemorrhage.
• Medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable during the course of the study.

You may not qualify if:

• Ocular concomitant conditions/ diseases
• Concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment
• Active intraocular inflammation (grade trace or above) in either eye
• Any active infection (e.g. conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in either eye
• History of uveitis in either eye
• Ocular disorders in the study eye that may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 12-month study period, including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause (e.g., age-related macular degeneration, ocular histoplasmosis, or pathologic myopia)
• Uncontrolled glaucoma in the study eye (according to investigator's judgment)
• Neovascularization of the iris in study eye
• Evidence of vitreomacular traction in study eye
• Ocular treatments
• Panretinal laser photocoagulation in the study eye within 6 months or focal/grid laser photocoagulation in the study eye within 3 months prior to study entry
• Treatment with anti-angiogenic drugs (pegaptanib sodium, anecortave acetate, bevacizumab, ranibizumab, etc.) or intravitreal corticosteroids in either eye within 4 months prior to randomization
• Any intraocular surgery in the study eye within 3 months prior to randomization
• History of vitrectomy in study eye
• Phakic study eye with a history of intravitreal corticosteroid treatment

Sponsors & Collaborators

• Hospital Regional de São José - Dr. Homero de Miranda Gomes: lead

Study Sites (1)

Marcelo Novello

São José, Santa Catarina, 88103-901, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy; Vitreous Hemorrhage

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Eye Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marcelo Novello

  Hospital Regional Sao Jose

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Marcelo Novello, Chief

CONTACT

551832719094; mbnovell@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: April 4, 2013
• Study Start: March 1, 2013
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 4, 2013

Record last verified: 2013-04

Locations

BR (1)