Protocol for a Randomized Controlled Trial Comparing Intravitreal Brolucizumab with Placebo for Chronic Central Serous Chorioretinopathy with Persistent Macular Fluid Without Choroidal Neovascular Membrane - BRICS Report #1.

Srishti Raksheeth Ramamurthy, Saarang Hansraj, Ritesh Narula, SriniVas R Sadda, Sobha Sivaprasad, Jay K Chhablani, Mudit Tyagi, Nikitha Gurram Reddy, Umesh Chandra Behera, Raja Narayanan
Author Information
  1. Srishti Raksheeth Ramamurthy: Smt Kanuri Santhamma Centre for Vitreoretinal diseases, Anant Bajaj Retina Institute, Kallam Anji Reddy Campus, LV Prasad Eye Institute, Hyderabad, India.
  2. Saarang Hansraj: Smt Kanuri Santhamma Centre for Vitreoretinal diseases, Anant Bajaj Retina Institute, Kallam Anji Reddy Campus, LV Prasad Eye Institute, Hyderabad, India.
  3. Ritesh Narula: Smt Kanuri Santhamma Centre for Vitreoretinal diseases, Anant Bajaj Retina Institute, Kallam Anji Reddy Campus, LV Prasad Eye Institute, Hyderabad, India.
  4. SriniVas R Sadda: Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, CA, USA.
  5. Sobha Sivaprasad: NIHR Moorfields Biomedical Research Center, Moorfields Eye Hospital NHS Foundation Trust, London, UK.
  6. Jay K Chhablani: Department of Ophthalmology, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
  7. Mudit Tyagi: Smt Kanuri Santhamma Centre for Vitreoretinal diseases, Anant Bajaj Retina Institute, Kallam Anji Reddy Campus, LV Prasad Eye Institute, Hyderabad, India.
  8. Nikitha Gurram Reddy: Smt Kanuri Santhamma Centre for Vitreoretinal diseases, Anant Bajaj Retina Institute, Kallam Anji Reddy Campus, LV Prasad Eye Institute, Hyderabad, India.
  9. Umesh Chandra Behera: Department of Vitreoretinal Diseases, Anant Bajaj Retina Institute, Mithu Tulsi Chanrai Campus, LV Prasad Eye Institute, Bhubaneshwar, India.
  10. Raja Narayanan: Smt Kanuri Santhamma Centre for Vitreoretinal diseases, Anant Bajaj Retina Institute, Kallam Anji Reddy Campus, LV Prasad Eye Institute, Hyderabad, India. ORCID

Abstract

PURPOSE: Established consensus is lacking for the management of chronic central serous chorioretinopathy (CSCR). The role of anti-VEGF agents in treating chronic CSCR in the absence of choroidal neovascular membrane (CNVM) is equivocal. We aim to study intravitreal brolucizumab in the treatment of persistent macular fluid in chronic CSCR without CNVM.
METHODS: This study is a prospective randomized, placebo-controlled trial to be conducted among 42 patients with chronic CSCR (>3 months duration) with persistent intraretinal and/or subretinal fluid. patients will be randomized in a 1:1 ratio to receive brolucizumab or oral multivitamins. Primary endpoint will be fluid resolution on OCT at 1 and 3 months. Secondary outcome measures will include the best-corrected visual acuity, microperimetry and NEI-VFQ 25 subjective questionnaire.
CONCLUSION: The results of this study will provide an understanding of the efficacy and safety of brolucizumab in achieving fluid resolution in chronic CSCR without CNVM.

Keywords

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Created with Highcharts 10.0.0CSCRchronicfluidwillCNVMstudybrolucizumabpersistentwithoutrandomizedresolutionBrolucizumabPURPOSE:Establishedconsensuslackingmanagementcentralserouschorioretinopathyroleanti-VEGFagentstreatingabsencechoroidalneovascularmembraneequivocalaimintravitrealtreatmentmacularMETHODS:prospectiveplacebo-controlledtrialconductedamong42patients>3 monthsdurationintraretinaland/orsubretinalPatients1:1ratioreceiveoralmultivitaminsPrimaryendpointOCT13 monthsSecondaryoutcomemeasuresincludebest-correctedvisualacuitymicroperimetryNEI-VFQ25subjectivequestionnaireCONCLUSION:resultsprovideunderstandingefficacysafetyachievingProtocolRandomizedControlledTrialComparingIntravitrealPlaceboChronicCentralSerousChorioretinopathyPersistentMacularFluidWithoutChoroidalNeovascularMembrane-BRICSReport#1complex

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