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Intravitreal Ranibizumab (Lucentis®) in the Treatment of Non-leaking Macular Cysts in Retinal Dystrophy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03763227
Recruitment Status : Completed
First Posted : December 4, 2018
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Sultan Qaboos University

Brief Summary:

To evaluate the efficacy and safety of intravitreal ranibizumab (IVR) injection in the treatment of non-leaking macular cysts in patients with retinal dystrophy.

Material and Methods:

Design - Prospective, nonrandomized, nonblinded, clinical trial. Participants - Patients >18 years diagnosed with retinal dystrophies and non-leaking macular cysts between Jan 2015 and July 2018 in 1 center.

Methods - Phase 1: Patients with best corrected visual acuity (BCVA) < 0.5 will receive carbonic anhydrase inhibitors (CAI) [oral acetazolamide 500mg/day or topical brinzolamide twice daily] and followed up for three months. Phase 2: Patients who do not show an adequate response with CAI will receive three 0.5mg IVR injection at monthly intervals.

Outcome - 1) Significant reduction (> 10%) of the central macular thickness (CMT), 2) Improvement (> 1 line) in BCVA 3) Presence of any complication.


Condition or disease Intervention/treatment Phase
Retinal Dystrophies Drug: Intravitreal ranibizumab (IVR) injection Drug: Carbonic Anhydrase Inhibitor (CAI) therapy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Phase 1: Patients with best corrected visual acuity (BCVA) < 0.5 will receive carbonic anhydrase inhibitors (CAI) [oral acetazolamide 500mg/day or topical brinzolamide twice daily] and followed up for three months. Phase 2: Patients who do not show an adequate response with CAI will receive three 0.5mg IVR injection at monthly intervals.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Intravitreal Ranibizumab (Lucentis®) Injection in the Treatment of Non-leaking Macular Cysts in Patients With Retinal Dystrophy.
Actual Study Start Date : July 24, 2015
Actual Primary Completion Date : August 29, 2019
Actual Study Completion Date : August 29, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Active Comparator: Carbonic Anhydrase Inhibitor (CAI) Arm
Patients who have received carbonic anhydrase inhibitor (CAI) therapy namely oral acetazolamide or topical brinzolamide
Drug: Carbonic Anhydrase Inhibitor (CAI) therapy
Carbonic anhydrase therapy (Oral or Topical) in patients with retinal dystrophy and macular cysts
Other Name: CAI

Experimental: Intravitreal ranibizumab (IVR) arm

Intravitreal ranibizumab (IVR) injection administered to patients who have not shown adequate response or who have not tolerated CAI therapy

IVR therapy = Three 0.5mg IVR injection at monthly intervals

Drug: Intravitreal ranibizumab (IVR) injection
Intravitreal ranibizumab (IVR) injection in patients with retinal dystrophy and macular cysts who have not responded to treatment with carbonic anhydrase inhibitors




Primary Outcome Measures :
  1. Macular Cyst [ Time Frame: 3 months ]
    Reduction in central macular thickness by 10%

  2. Macula [ Time Frame: 3 months ]
    Improvement in visual acuity by over one line

  3. Complications [ Time Frame: 3 months ]
    Presence of any complications from treatment



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:   No
Criteria

Inclusion Criteria:

Omani patients over 18 year old, with retinal dystrophy and non-leaking macular cysts confirmed by fundus examination, electroretinography (ERG), optical coherence tomography (OCT), fundus fluorescein angiography (FFA) and genetic testing.

Included patients should also have the capacity and cooperation to undergo visual function assessment (i.e. best-corrected visual acuity (BCVA), color vision as well as the above-mentioned investigations.

Exclusion Criteria:

Patients with pseudo-retinitis pigmentosa, those with cystic macular lesions or progressive retinal disease due to any cause other than retinal dystrophy, and patients with reduced visual acuity due to media opacities (e.g. cataract). Patients with any contraindication or known allergy to brinzolamide, acetazolamide or anti-VEGF agents will not receive the respective drug, nor those who underwent intraocular surgery or injection within the last 1 month.


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): NCT03763227


Sponsors and Collaborators
Sultan Qaboos University
Investigators
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Study Chair: Anuradha Ganesh, MD Sultan Qaboos University Hospital
Publications:
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Responsible Party: Sultan Qaboos University
ClinicalTrials.gov Identifier: NCT03763227    
Other Study ID Numbers: MREC 883
First Posted: December 4, 2018    Key Record Dates
Last Update Posted: September 23, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Retinal Dystrophies
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Carbonic Anhydrase Inhibitors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action