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Effects of 0.1% Nepafenac on Vitreous Inflammatory Biomarkers in Rhegmatogenous Retinal Detachment and Proliferative Vitreoretinopathy

NCT07162818 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-09-09

No results posted yet for this study

Summary

PVR remains the major cause of surgical failure in RRD repair.1 Prompt surgical management is the standard therapy in RRD repair. However, in many places, vitreoretinal (VR) surgery facilities is limited, such as in Indonesia, where mainly located within referral hospitals. Until recently, there has been no recommended pharmacological therapy before surgery to prevent the formation of PVR in RRD. . Previous studies involving the use of pharmacological agents, such as anti-inflammatory and anti-proliferative agents, have been reported to prevent the development of PVR. Nepafenac 0.1% eye drops is a potent NSAID that has been proven effective in preventing macular edema in cases of post-cataract surgery and diabetic retinopathy. This study aims to compare the levels of vitreous inflammatory biomarkers in RRD following the administration of preoperative nepafenac 0.1%.

The inclusion criteria were patients of the age of 18 years old and above with macula-off RRD, grade A or B PVR, and RRD onset upon examination up to 1 month. The exclusion criteria included RRD patients with media opacification, a history of intraocular surgery in less than 3 months, other eye disease comorbidities (i.e., macular hole, epiretinal membrane), other systemic diseases, and a history of NSAID allergy.

Conditions

  • Proliferative Vitreoretinopathy
  • Rhegmatogenous Retinal Detachment

Interventions

DRUG

Nepafenac 0.1% eyedrops

The study eye drops were nepavenac 0.1% eye drops (NEVANAC 0.1%®, Alcon Laboratories, Inc., Fort Worth, Texas). Subjects were instructed to use eye drops on the side of the eye with the ARR, three times daily for five days before and on the day of surgery. Written instructions and a daily checklist to record the eye drop schedule were provided to each subject.

DRUG

Control (placebo) group

Cenfresh® eye drops (Cendo pharmaceutical, Indonesia) for the control group. Subjects were instructed to use eye drops on the side of the eye with the ARR, three times daily for five days before and on the day of surgery. Written instructions and a daily checklist to record the eye drop schedule were provided to each subject.

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Principal Investigators

  • Ari Djatikusumo, MD · Department of Ophthalmology, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital, Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-28
Primary Completion
2021-12-01
Completion
2021-12-01

Countries

  • Indonesia

Study Locations

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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 NCT07162818 on ClinicalTrials.gov