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

NCT03763227 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: MREC 883
• Study Type: interventional
• Target: 13
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Retinal Dystrophies

Outcome Measures

Primary Outcomes (3)

• Macular Cyst

  Reduction in central macular thickness by 10%

  3 months

• Macula

  Improvement in visual acuity by over one line

  3 months

• Complications

  Presence of any complications from treatment

  3 months

Study Arms (2)

Carbonic Anhydrase Inhibitor (CAI) Arm

ACTIVE COMPARATOR

Patients who have received carbonic anhydrase inhibitor (CAI) therapy namely oral acetazolamide or topical brinzolamide

Drug: Carbonic Anhydrase Inhibitor (CAI) therapy

Intravitreal ranibizumab (IVR) arm

EXPERIMENTAL

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

Interventions

Intravitreal ranibizumab (IVR) injection DRUG

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

Intravitreal ranibizumab (IVR) arm

Carbonic Anhydrase Inhibitor (CAI) therapy DRUG

Carbonic anhydrase therapy (Oral or Topical) in patients with retinal dystrophy and macular cysts

Also known as: CAI

Carbonic Anhydrase Inhibitor (CAI) Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sultan Qaboos University: lead

Related Publications (4)

• Moustafa GA, Moschos MM. Intravitreal aflibercept (Eylea) injection for cystoid macular edema secondary to retinitis pigmentosa - a first case report and short review of the literature. BMC Ophthalmol. 2015 Apr 30;15:44. doi: 10.1186/s12886-015-0033-z.

  PMID: 25925748 BACKGROUND

• Artunay O, Yuzbasioglu E, Rasier R, Sengul A, Bahcecioglu H. Intravitreal ranibizumab in the treatment of cystoid macular edema associated with retinitis pigmentosa. J Ocul Pharmacol Ther. 2009 Dec;25(6):545-50. doi: 10.1089/jop.2009.0089.

  PMID: 20028262 BACKGROUND

• Yuzbasioglu E, Artunay O, Rasier R, Sengul A, Bahcecioglu H. Intravitreal bevacizumab (Avastin) injection in retinitis pigmentosa. Curr Eye Res. 2009 Mar;34(3):231-7. doi: 10.1080/02713680802710692.

  PMID: 19274531 BACKGROUND

• Miyata M, Oishi A, Oishi M, Hasegawa T, Ikeda HO, Tsujikawa A. Long-term efficacy and safety of anti-VEGF therapy in retinitis pigmentosa: a case report. BMC Ophthalmol. 2018 Sep 14;18(1):248. doi: 10.1186/s12886-018-0914-z.

  PMID: 30217183 BACKGROUND

MeSH Terms

Conditions

Retinal Dystrophies

Interventions

Injections; Carbonic Anhydrase Inhibitors; carboxyamido-triazole; Therapeutics

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Anuradha Ganesh, MD

  Sultan Qaboos University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: December 1, 2018
• First Posted: December 4, 2018
• Study Start: July 24, 2015
• Primary Completion: August 29, 2019
• Study Completion: August 29, 2019
• Last Updated: September 23, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share