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

Sponsor
Sultan Qaboos University
Study ID
NCT03763227
Phase
PHASE2
Status
Completed

Conditions

  • Retinal Dystrophies

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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
  • Carbonic Anhydrase Inhibitor (CAI) therapy — DRUG
    Carbonic anhydrase therapy (Oral or Topical) in patients with retinal dystrophy and macular cysts

Study Details

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.

Key Dates

First listed
Dec 4, 2018
Start date
Jul 24, 2015
Status verified
Sep 2019
Primary completion
Aug 29, 2019
Completion
Aug 29, 2019

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Carbonic Anhydrase Inhibitor (CAI) Arm
    Patients who have received carbonic anhydrase inhibitor (CAI) therapy namely oral acetazolamide or topical brinzolamide
  • 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

Primary Outcome Measure

Macular Cyst [ Time Frame: 3 months ]

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