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Comparison of Efficacy and Safety of Mitomycin and Aflibercept Used to Support Primary Trabeculectomy.

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ClinicalTrials.gov Identifier: NCT03766425
Recruitment Status : Active, not recruiting
First Posted : December 6, 2018
Last Update Posted : December 6, 2018
Sponsor:
Information provided by (Responsible Party):
Justyna Kaproń-Świś, Medical University of Lublin

Brief Summary:
Comparison of efficacy and safety of Mitomycin and Aflibercept used to support primary trabeculectomy - a prospective, randomized trial in patients with open-angle glaucoma undergoing surgery.

Condition or disease Intervention/treatment Phase
Eye Diseases Optic Nerve Damage Glaucoma Surgery Drug: Aflibercept Drug: Mitomycin Early Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comparison of Efficacy and Safety of Mitomycin and Aflibercept Used to Support Primary Trabeculectomy - a Prospective, Randomized Trial in Patients With Open-angle Glaucoma Undergoing Surgery.
Actual Study Start Date : June 14, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2019


Arm Intervention/treatment
Experimental: Aflibercept
Aflibercept applied intraoperatively as a subconjunctival injection at a dose of 0.05 ml (40 mg / ml) and one week after the operation at the same dose, also subconjunctival.
Drug: Aflibercept
subconjunctival injection
Other Name: Eylea, Zaltrap

Active Comparator: Mitomycin
Mitomycin applied during a surgery at a concentration of 0.3mg / ml for 3 min. on a soaked sponge.
Drug: Mitomycin
subconjunctival injection
Other Name: Ametycine, Mit-C, Mitomycin C




Primary Outcome Measures :
  1. Effectiveness of aflibercept and mitomycin on the morphology of the bleb; [ Time Frame: 1 year ]
    Rating the bleb in The Indiana Bleb Appearance Grading Scale, describing bleb height, extent, vascularity, and leakage with the Seidel test.

  2. Effectiveness of aflibercept and mitomycin on the function of the bleb; [ Time Frame: 1 year ]
    Measurement of intraocular pressure (Goldmann applanation tonometer) and taking a photo of a bleb.


Secondary Outcome Measures :
  1. Impact of tested substances on visual acuity after surgery [ Time Frame: 1 year ]
    Examination of a visual acuity 1 week after operation as well as 1 month, 3 months, 6 months, 12 months

  2. The influence of aflibercept and mitomycin on corneal endothelial cell density after surgery [ Time Frame: 1 year ]
    Examination of the corneal endothelial cell density before the surgery as well as 6 months and 12 months after surgery

  3. Impact of used substances on visual field parameters [ Time Frame: 1 year ]
    Examination of a visual field in SITA (Swedish Interactive Testing Algorithm) FAST strategy before the surgery and 12 months after surgery

  4. Frequencies and type of possible complications. [ Time Frame: 1 year ]
    observing and recording all complications and side effects in both groups of patients



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Primary open-angle glaucoma or capsular glaucoma.
  2. Patient's age: over 40 years, no sex preference;
  3. Local treatment ineffective due to:

    1. Intraocular pressure above 21mmHg at maximum pharmacological therapy (using β-blocker + carbonic anhydrase inhibitor + prostaglandins) or
    2. Intolerance to topical treatment or
    3. Progression in visual field examination
  4. Lack of previous ophthalmological surgical interventions.
  5. Lack of previously performed laser gonioplasty.
  6. No laser trabeculoplasty or laser trabeculoplasty performed for more than a year.

Exclusion Criteria:

  1. Patient with primary closed-angle glaucoma or secondary glaucoma (except for glaucoma in the course of pseudoexfoliation syndrome).
  2. One-eye patient.
  3. Patient with aphakia.
  4. Patient after previous ophthalmic procedures (cataract removal by phacoemulsification with an implant of an intraocular lens, vitrectomy by pars plana, keratoplasty).
  5. A patient diagnosed or suspected of having uveitis or intraocular inflammation.
  6. Any corneal abnormalities or other conditions that prevent reliable testing with an applanation device in the treated eye, including earlier refractive surgery of the eye.

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): NCT03766425


Locations
Poland
Medical University of Lublin
Lublin, Lubelskie, Poland, 20-059
Sponsors and Collaborators
Medical University of Lublin

Responsible Party: Justyna Kaproń-Świś, Medical Doctor, Medical University of Lublin
ClinicalTrials.gov Identifier: NCT03766425     History of Changes
Other Study ID Numbers: KE-0254/133/2017
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: December 6, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Justyna Kaproń-Świś, Medical University of Lublin:
aflibercept
glaucoma
mitomycin
trabeculectomy

Additional relevant MeSH terms:
Eye Diseases
Glaucoma
Optic Nerve Injuries
Ocular Hypertension
Cranial Nerve Injuries
Cranial Nerve Diseases
Nervous System Diseases
Optic Nerve Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors