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

NCT ID: NCT07162818

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-28
• Study Completion Date: 2021-12-01

Brief 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.

Detailed Description

Prospective subjects underwent Vital signs, an eye examination, fundus biomicroscopy, fundus photographs, and an Optical Coherent Tomography (OCT) scan of the macula were performed. This initial eye examination determined the degree of PVR before intervention was administered.

If they met the inclusion criteria, potential subjects were recruited and randomized, allocating the subjects to two groups: an intervention group with nepavenac 0.1% eye drops and a control group with Cenfresh® eye drops, administered 5 days before the vitrectomy. The medication labels were removed and replaced with the study labels.

The subjects were then prepared for surgery by undergoing blood tests, an EKG, and consultation with an anesthesiologist in the perioperative clinic of the Department of Anesthesia, RSCM/FKUI. The surgery was performed in the operating room of the Department of Ophthalmology, FKUI/RSCM Kirana, according to a predetermined schedule, which was after the subjects had used the eye drops for 5 days, 3 times daily. Written instructions and a daily checklist to record the medication drop schedule were provided to each subject.

On the day of surgery, a repeat fundus biomicroscopy examination, fundus photographs, and an OCT macular scan were performed to record the degree of PVR before the vitrectomy. Vitreous samples were taken during vitrectomy to assess vitreous biomarker levels.

After vitrectomy, all subjects underwent follow-up examinations on days 1, 7, and 28 to assess the surgical outcome. At each visit, routine examinations were performed, including vital signs, an eye examination, and fundus biomicroscopy. Fundus photographs and OCT scans were performed three times:

On the first visit during recruitment, the second visit on the day of surgery, and the final one on day 28 postoperatively. All examination results were recorded in the outpatient record at each visit.

Conditions

Proliferative Vitreoretinopathy; Rhegmatogenous Retinal Detachment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Nepafenac 0.1% eyedrops

Nepafenac 0.1% is a topical NSAID pro-drug for the eye.

Group Type: EXPERIMENTAL

Nepafenac 0.1% eyedrops

Intervention Type: DRUG

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.

Control

Cenfresh® sterile eye drops in 5 mL packaging containing 5mg Carmellose sodium

Group Type: PLACEBO_COMPARATOR

Control (placebo) group

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• ARR with PVR grade A and B
• ARR onset more than 7 days and less than 1 month
• Macula off
• ARR patients with a minimum age of 18 years.
• Willing to follow the research stages and sign the informed consent.

Exclusion Criteria

• ARR patients with media opacities that do not allow fundus examination
• History of undergoing intraocular surgery less than 3 months.
• ARR patients with comorbid eye diseases.
• ARR patients with systemic complications that make it impossible to undergo vitrectomy surgery.
• ARR sufferers who are known to have a history of allergies to the NSAID group.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Dr.dr. Ari Djatikusumo, Sp. M(K).

Head of Ophthalmology Department, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital, Indonesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ari Djatikusumo, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Ophthalmology, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital, Indonesia

Locations

Department of Ophthalmology, Faculty of Medicine Universitas Indonesia Cipto Mangunkusumo Hospital

Jakarta, Jakarta Pusat, Indonesia

Countries

Indonesia

Other Identifiers

PUTI Saintekes 2022 Grant

Identifier Type: OTHER

Identifier Source: secondary_id

21-01-0081

Identifier Type: -

Identifier Source: org_study_id