Trial record 8 of 28 for:    Open Studies | "Retinal Detachment"

Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified October 2013 by King Khaled Eye Specialist Hospital
Sponsor:
Collaborator:
Pan American Collaborative Retina Study Group
Information provided by (Responsible Party):
J. Fernando Arevalo, MD FACS, King Khaled Eye Specialist Hospital
ClinicalTrials.gov Identifier:
NCT01976923
First received: October 25, 2013
Last updated: October 30, 2013
Last verified: October 2013
  Purpose

The purpose of this is study is to assess the efficacy of pre-operative intravitreal bevacizumab (IVB) (Genentech, South San Francisco CA) in improving visual acuity, reducing operative time, complications, intra-operative and post-operative hemorrhage following small gauge pars plana vitrectomy (PPV) (23-gauge, 25-gauge or 27-gauge ) compared to small gauge PPV (23-gauge, 25-gauge or 27-gauge) alone in eyes with tractional retinal detachment (TRD) secondary to proliferative diabetic retinopathy (PDR). Hypothesis: Preoperative IVB may be beneficial for membrane dissection in diabetic tractional retinal detachment with minimally invasive vitreoretinal surgery (23-gauge transconjunctival sutureless vitrectomy [TSV]). In addition, post-operative rebleeding may be decreased.


Condition Intervention Phase
Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy
Drug: Intravitreal bevacizumab
Procedure: Small-gauge pars plana vitrectomy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pre-Operative Intravitreal Bevacizumab for Tractional Retinal Detachment Secondary to Proliferative Diabetic Retinopathy: Results of the Pan-American Collaborative Retina Study (PACORES) Group

Resource links provided by NLM:


Further study details as provided by King Khaled Eye Specialist Hospital:

Primary Outcome Measures:
  • Intraoperative bleeding [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Total surgical time [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Post-operative vitreous hemorrhage [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Early (<1 month) and late (≥ 1 month) post-operative vitreous hemorrhage (VH) (Yes or No)

  • Visual acuity change [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Mean change in best-corrected visual acuity (BCVA) at 12 months


Secondary Outcome Measures:
  • Number of endodiathermy applications [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Intraoperative breaks [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Change in central macular thickness [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Proportion of eyes gaining at least 15 letters of BCVA [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Molecules in the vitreous humor and epiretinal membranes [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    We would now like to examine molecules in the vitreous humor and epiretinal membranes to gain insight and better assess the efficacy and outcomes of pre-operative intravitreal bevacizumab.


Estimated Enrollment: 374
Study Start Date: November 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Study arm
Intravitreal bevacizumab Small-gauge pars plana vitrectomy
Drug: Intravitreal bevacizumab
A sterile lid speculum is used to separate the lids. A subconjunctival injection of 1% lidocaine is applied to the inferotemporal quadrant. A 5% povidone iodine solution is used to disinfect the entire conjunctival surface. 1.25 mg / 0.05 mL of bevacizumab is injected using a 30-gauge needle inserted through the inferotemporal pars plana 3.5 mm from the limbus.
Procedure: Small-gauge pars plana vitrectomy
Sham Comparator: Control arm
Small-gauge pars plana vitrectomy
Procedure: Small-gauge pars plana vitrectomy

Detailed Description:

This will be a prospective, randomized, active-controlled study of 374 eyes of patients with the diagnosis of TRD secondary to PDR. Participants will be screened for eligibility. Eligible patients will be examined at baseline to determine their ocular condition and randomized into 2 arms. Patients will be randomized in a 3:1 ratio to the study arm.

  1. Control arm: PPV without pre-operative bevacizumab (Sham injection).
  2. Study arm: Pre-operative bevacizumab (3-5 days) before PPV.

In the study arm, an intravitreal bevacizumab injection at a dose of 1.25 µg/0.05 mL will be scheduled 3 to 5 days before minimally invasive vitreoretinal surgery (MIVS).

The purpose of the current study is to determine the effectiveness and safety of an intravitreal injection of 1.25 mg of bevacizumab as a pre-operative adjunct to PPV in eyes with TRD secondary to PDR.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age >= 18 years with proliferative diabetic retinopathy (PDR) and tractional retinal detachment (TRD) threatening or involving the fovea.
  2. Diagnosis of diabetes mellitus (type 1 or type 2)
  3. At least one eye meets the study eye criteria
  4. One eye per patient will be included
  5. Able and willing to provide informed consent prior to any study-related procedures
  6. Best corrected visual acuity 20/40 or less
  7. Willing and able to comply with clinic visits and study-related procedures
  8. U.S. patients will be required to have a Health Insurance Portability and Accountability Act (HIPAA) authorization; in other countries, as applicable according to national laws

Exclusion Criteria:

Ocular Exclusion Criteria

The following exclusions apply to the study eye only (i.e., they may be present for the non-study eye):

  1. TRD is considered to be due to a cause other than diabetes.
  2. An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of TRD (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition, optic atrophy).
  3. An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect retinal status or alter visual acuity during the course of the study (e.g., retinal vein occlusion, uveitis or other ocular inflammatory disease, glaucoma, etc.)
  4. History of treatment for diabetic macular edema or diabetic retinopathy at any time in the past 4 months with anti-vascular endothelial growth factor (VEGF) drugs.
  5. History of major ocular surgery (including vitrectomy, cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months of randomization.
  6. History of neodymium-doped yttrium aluminium garnet (YAG) capsulotomy performed within 2 months prior to randomization.
  7. Intraocular pressure >= 25 mmHg.
  8. Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis
  9. An ocular condition is present (other than diabetes) that, in the opinion of the investigator, might affect retinal status or including hypertension, cardiovascular disease, and glycemic control.

Systemic Exclusion Criteria

A participant is not eligible if any of the following exclusion criteria are present:

  1. Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
  2. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including hypertension, cardiovascular disease, and glycemic control).
  3. Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
  4. Known allergy to any component of the study drug.
  5. Blood pressure > 180/110 mmHg (systolic above 180 or diastolic above 110).
  6. Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.
  7. Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
  8. Systemic anti-VEGF or VEGF treatment within 4 months prior to randomization.
  9. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
  10. Participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the first 12 months of the study.
  11. Participation in an investigational trial within 30 days of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
  12. Known allergy to any component of the study drug.
  13. Blood pressure > 180/110 mmHg (systolic above 180 or diastolic above 110).
  14. Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.
  15. Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization.
  16. Systemic anti-VEGF or VEGF treatment within 4 months prior to randomization.
  17. For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
  18. Participant is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the first 12 months of the study.
  19. History of blood diseases associated with abnormal coagulation.
  20. Anti-coagulant therapy (warfarin or heparin).
  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: NCT01976923

Contacts
Contact: J. Fernando Arevalo, MD, FACS +966 (11) 482-1234 ext 3860 arevalojf@jhmi.edu
Contact: Igor Kozak, MD +966 (11) 482-1234 ext 3772 ikozak@kkesh.med.sa

Locations
Saudi Arabia
King Khaled Eye Specialist Hospital Not yet recruiting
Riyadh, Saudi Arabia, 11462
Contact: J. Fernando Arevalo, MD, FACS    +966 (11) 482-1234 ext 3860    arevalojf@jhmi.edu   
Contact: Igor Kozak, MD    +966 (11) 482-1234 ext 3772    ikozak@kkesh.med.sa   
Principal Investigator: J. Fernando Arevalo, MD, FACS         
Principal Investigator: Igor Kozak, MD         
Sub-Investigator: Saba Al Rashaed, MD         
Sub-Investigator: Eman Al Kahtani, MD         
Sub-Investigator: Vishali Gupta, MD         
Sub-Investigator: Alka Mahale, PhD         
Sponsors and Collaborators
J. Fernando Arevalo, MD FACS
Pan American Collaborative Retina Study Group
  More Information

Publications:
Responsible Party: J. Fernando Arevalo, MD FACS, Chief of Vitreoretina Division, King Khaled Eye Specialist Hospital
ClinicalTrials.gov Identifier: NCT01976923     History of Changes
Other Study ID Numbers: 1338-P
Study First Received: October 25, 2013
Last Updated: October 30, 2013
Health Authority: Saudi Arabia: Saudi Food and Drug Administration

Keywords provided by King Khaled Eye Specialist Hospital:
Intravitreal Bevacizumab
Tractional Retinal Detachment
Proliferative Diabetic Retinopathy
Small gauge pars plana vitrectomy
Intraoperative bleeding
Post-operative vitreous hemorrhage
Visual acuity

Additional relevant MeSH terms:
Retinal Detachment
Diabetic Retinopathy
Retinal Diseases
Dissociative Disorders
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Mental Disorders
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014