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

NCT03763227 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2019-09-23

No results posted yet for this study

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

Interventions

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

DRUG

Carbonic Anhydrase Inhibitor (CAI) therapy

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

Sponsors & Collaborators

  • Sultan Qaboos University

    lead OTHER

Principal Investigators

  • Anuradha Ganesh, MD · Sultan Qaboos University Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-24
Primary Completion
2019-08-29
Completion
2019-08-29
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03763227 on ClinicalTrials.gov