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Steroids and/ or Non-steroidal Anti-inflammatory Drugs in the Postoperative Regime After Trabeculectomy. (SNAP)

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ClinicalTrials.gov Identifier: NCT04054830
Recruitment Status : Recruiting
First Posted : August 13, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
Afrouz Ahmadzadeh, Rigshospitalet, Denmark

Brief Summary:

PURPOSE:

Glaucoma is the leading cause of non-curable blindness globally. Patients with glaucoma will get a gradual narrowing of the visual fields caused by compression at the optic nerve head due to increased intraocular pressure. Thus the main preventive strategy is to reduce intraocular pressure, initially by eye drops and/or laser treatment but in some patients surgery is warranted. The surgical procedure (trabeculectomy) most widely performed worldwide creates a path from the anterior chamber to the subconjunctival space and thereby lowers the IOP by producing a more efficient drainage of the aqueous humour. Surgical success depends upon controlling post-operative inflammation to ensure a functional drainage. The purpose of this blinded, randomized study is to investigate which anti-inflammatory treatment provides better long-term control of intra-ocular pressure (IOP) following glaucoma surgery (trabeculectomy) by comparing topical NSAIDs to topical steroids. Additionally, we want to explore the mechanisms behind the pathophysiology of glaucoma by evaluating retinal and optic nerve head perfusion before and after IOP lowering surgery. The primary outcome is the intraocular pressure 12 months after surgery measured by applanation tonometry.

MAIN HYPOTHESIS:

  • NSAIDs and steroids are equally effective in assuring long-term filtering function and controlling IOP after trabeculectomy but may be associated with different risk profiles and bleb morphology
  • Patients with lower post-operative IOP demonstrate less progression of visual field loss
  • Trabeculectomy lowers IOP and provides better microcirculation in and oxygenation of inner retinal layers (i.e. ganglion cell layer) and the optic nerve head

Condition or disease Intervention/treatment Phase
Glaucoma Drug: Voltaren Ophtha 1 mg/ml, GSK Drug: Monopex 1 mg/ml, Théa Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Steroids and/ or Non-steroidal Anti-inflammatory Drugs in the Postoperative Regime After Trabeculectomy. An Investigator-initiated Randomized Study (The SNAP Study)
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Topical, preservative-free NSAID
Topical medication are to be used 6 times daily for the 2 first weeks, tapering to 4 drops per day for the next 4 weeks. Depending on the clinical condition of the eye, the topical anti-inflammatory treatment will be reduced with 1 daily drop per week.
Drug: Voltaren Ophtha 1 mg/ml, GSK
Voltaren Ophtha 1 mg/ml, eye drops used 6 times daily for the 2 first weeks, tapering to 4 drops per day for the next 4 weeks. Depending on the clinical condition of the eye, the topical anti-inflammatory treatment will be reduced with 1 daily drop per week.

Active Comparator: Topical, preservative-free steroid
Topical medication are to be used 6 times daily for the 2 first weeks, tapering to 4 drops per day for the next 4 weeks. Depending on the clinical condition of the eye, the topical anti-inflammatory treatment will be reduced with 1 daily drop per week.
Drug: Monopex 1 mg/ml, Théa
Monopex 1 mg/ml, eye drops used 6 times daily for the 2 first weeks, tapering to 4 drops per day for the next 4 weeks. Depending on the clinical condition of the eye, the topical anti-inflammatory treatment will be reduced with 1 daily drop per week.

Experimental: Topical, preservative-free NSAID (Voltaren Ophtha 1 mg/ml, GSK
Topical medication are to be used 6 times daily for the 2 first weeks, tapering to 4 drops per day for the next 4 weeks. Depending on the clinical condition of the eye, the topical anti-inflammatory treatment will be reduced with 1 daily drop per wee
Drug: Voltaren Ophtha 1 mg/ml, GSK
Voltaren Ophtha 1 mg/ml, eye drops used 6 times daily for the 2 first weeks, tapering to 4 drops per day for the next 4 weeks. Depending on the clinical condition of the eye, the topical anti-inflammatory treatment will be reduced with 1 daily drop per week.

Drug: Monopex 1 mg/ml, Théa
Monopex 1 mg/ml, eye drops used 6 times daily for the 2 first weeks, tapering to 4 drops per day for the next 4 weeks. Depending on the clinical condition of the eye, the topical anti-inflammatory treatment will be reduced with 1 daily drop per week.




Primary Outcome Measures :
  1. Intraocular pressure (IOP) [ Time Frame: 12 months ]
    Postoperative intraocular pressure (IOP) by applanation tonometry


Secondary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: 12 months, 24 months ]
    Postoperative best corrected visual acuity in logarithm to the minimal angle of resolution (logMAR)

  2. Visual field [ Time Frame: 12 months, 24 months ]
    Postoperative changes in visual field by octopus autoperimetry. (MD)

  3. Optical nerve damage [ Time Frame: 12 months, 24 months ]
    Optical nerve damage, assessed by measuring retinal nerve fiber layer (RNFL) by peripapillary optical coherence tomography (OCT)

  4. Surgical success [ Time Frame: 12 months, 24 months ]

    The definition of surgical success criteria is dependent on the the severity of visual field defect (MD, mean deviation of visual sensitivity compared to those expected from the age-matched normative database) glaucoma diagnosis and achievement of target pressure without the use of medication (complete success) or with the use of glaucoma medication (qualified success)

    • Ocular hypertension, target <25 mmHg
    • MD < 6 dB, target < 21 mmHg
    • MD 6 dB - 12 dB, target <18 mmHg
    • MD > 12 dB, target < 15 mmHg



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with primary open-angle glaucoma (POAG), pseudoexfoliation syndrome (PEX), pigment dispersion syndrome (PDS) or ocular hypertension
  • >50 years
  • Women must be postmenopausal. Women are asked if they have menstruated within the preceding 12 months
  • Scheduled to undergo trabeculectomy surgery at the Department of Ophthalmology at Rigshospitalet-Glostrup, Denmark
  • Informed consent to participation and ability to comply with study procedures

Exclusion Criteria:

  • Known allergy to any of the contents of the pharmaceuticals (active and in-active ingredients) used in the study
  • Prior intraocular surgery, except from cataract surgery. If cataract surgery has been performed, it should at least be 6 months prior to surgery
  • Medical history of anterior segment dysgenesis, inflammatory/uveitic glaucoma, angle closure glaucoma, neovascular glaucoma and traumatic glaucoma
  • Steroid responders
  • Pregnancy
  • Fertile women, i.e. women who are not menopausal and women who breastfeed
  • Patients in systemic treatment with steroid or NSAID

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): NCT04054830


Contacts
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Contact: Afrouz Ahmadzadeh, MD 004538634531 afrouz.ahmadzadeh.01@regionh.dk
Contact: Daniella Bach-Holm, MD, Ph.D. daniella.bach-holm.01@regionh.dk

Locations
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Denmark
Department of Ophthalmology Recruiting
Glostrup, Capital Region,, Denmark, 2600
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
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Principal Investigator: Daniella Bach-Holm, MD, Ph.D. Dpt. of Ophthalmology, Rigshospitalet-Glostrup

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Responsible Party: Afrouz Ahmadzadeh, MD, PhD-student, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04054830     History of Changes
Other Study ID Numbers: EudraCT nr.: 2018-001855-10
First Posted: August 13, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Afrouz Ahmadzadeh, Rigshospitalet, Denmark:
Trabeculectomy
NSAID
Steroid
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Eye Diseases

Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Diclofenac
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action