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Pain and Visual Outcome in Intravitreal Bevacizumab Injection (pain & visual)

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ClinicalTrials.gov Identifier: NCT02790775
Recruitment Status : Completed
First Posted : June 6, 2016
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences

Brief Summary:
In this double blind clinical trial, 1000 patients suffering from diabetic macular edema, age-related macular degeneration, neovascularization due to proliferative diabetic retinopathy and cystoid macular edema secondary to retinal vascular occlusions are included. Those with the history of Ocular pain prior to the procedure, any contraindication for Intravitreal Bevacizumab Injection (IVI), history of any kind of anterior segment conditions that could affect pain sensation, history of using systemic analgesic or sedative medications, history of previous eye surgery other than for cataract, glaucoma, uveitis and bullous keratopathy and poor cooperation in using the visual analogue scale (VAS) are excluded from the study. Before starting the treatment all patients undergo complete ophthalmic exam , best-corrected visual acuity (BCVA) checking and macular thickness measurements using optical coherence tomography (OCT). Patients are randomly assigned to each group .Each participant receive one injection in one eye in this study. Pain is measured by subjective grading on a Visual Analog Scale (VAS) immediately after IVI. BCVA and OCT would be checked again at month one.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Anti-VEGF in quadrant 1 Drug: Anti-VEGF in quadrant 2 Drug: Anti-VEGF in quadrant 3 Drug: Anti-VEGF in quadrant 4 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1004 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Evaluation of the Pain and Visual Outcome Associated With Location of Intravitreal Bevacizumab Injection
Study Start Date : December 2015
Actual Primary Completion Date : May 30, 2016
Study Completion Date : August 30, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Bevacizumab

Arm Intervention/treatment
Active Comparator: Injection Anti-VEGF in quadrant 1
Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 1
Drug: Anti-VEGF in quadrant 1
Active Comparator: Injection Anti-VEGF in quadrant 2
Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 2
Drug: Anti-VEGF in quadrant 2
Active Comparator: InjectionAnti-VEGF in quadrant 3
Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 3
Drug: Anti-VEGF in quadrant 3
Active Comparator: InjectionAnti-VEGF in quadrant 4
Each participant receive one injection Anti-vascular endothelial growth factor (Anti-VEGF) in one eye in the quadrant 4
Drug: Anti-VEGF in quadrant 4



Primary Outcome Measures :
  1. Pain [ Time Frame: immediately after Intravitreal Bevacizumab Injection ]
    Visual Analog Scale (VAS)


Secondary Outcome Measures :
  1. Best-corrected visual acuity (BCVA) [ Time Frame: preoperative and 1 month postoperatively. ]
    using Snellen chart



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • diabetic macular edema, age-related macular degeneration, neovascularization due to proliferative diabetic retinopathy and cystoid macular edema secondary to retinal vascular occlusions

Exclusion Criteria:

  • history of Ocular pain prior to the procedure, any contraindication for Intravitreal Bevacizumab Injection (IVI), history of any kind of anterior segment conditions that could affect pain sensation, history of using systemic analgesic or sedative medications, history of previous eye surgery other than for cataract, glaucoma, uveitis and bullous keratopathy and poor cooperation in using the visual analogue scale (VAS)

Information from the National Library of Medicine

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): NCT02790775


Locations
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Iran, Islamic Republic of
Islamic Republic of Iran
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University of Medical Sciences

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Responsible Party: Zahra Rabbani Khah, Ophthalmic Research center, Shahid Beheshti University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02790775     History of Changes
Other Study ID Numbers: 94312
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: September 2015
Additional relevant MeSH terms:
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Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors