Effect of Topical and Oral Diclofenac on Pain Related to Intravitreal Injections

NCT ID: NCT02837770

Last Updated: 2017-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2017-01-31

Brief Summary

The analgestic efffect of Diclofenac Sodium 0.1% Eye Drops and a combination of Diclofenac Sodium 0.1% Eye Drops and oral Diclofenac Sodium sustained-release 75mg tablets on pain related to intravitreal injections will be evalutated.

Pain perception will be assessed by the Short Form of the McGill Pain Questionnaire.

Detailed Description

Intravitreal injection (IVI) is a preferred route of administration of drugs in the posterior segment of the eye. Intravitreal injection of anti-VEGFs constitutes the mainstay for the treatment of various retinal diseases such as AMD, RVO, DME etc.

The procedure of the IVI is, however, associated with a level of discomfort for the patient.

Nonsteroidal anti-inflammatory drugs (NSAIDs) inhibit the activity of cyclooxygenase-1 and cyclooxygenase-2, and thereby, the synthesis of prostaglandins and thromboxanes. Cyclooxygenase-2 inhibition leads to the anti-inflammatory, analgesic and antipyretic effects of NSAIDs.

Ophthalmic NSAIDs constitute an established and effective treatment option for the management of inflammation and pain associated with cataract surgery and of pain associated with corneal refractive surgery, for inhibition of intraoperative miosis and for the treatment of seasonal allergic conjunctivitis.

The primary goal of this study is to assess the analgesic effect of DIclofenac 0.1% Eye Drops a topical NSAID, as well as a combination of Diclofenac 0.1% Eye Drops and oral Diclofenac Sodium sustained-release (SR) 75mg tablets on pain related to intravitreal injections immediately after and up to six hours post-IVI.

A number of patients scheduled to undergo IVIs of anti-VEGFs will be randomized and divided in three groups. All patients must have already undergone at least one IVI. In patients receiving IVIs in both eyes only one eye will be included in the study.

The patients of the first group will receive placebo pill 4 hours before the IVI and Diclofenac 0.1 % Eye Drops 45 minutes prior to the injection.

The patients of the second group will recieve oral Diclofenac Sodium SR 75mg/tb 4 hours prior to the injection and Diclofenac 0.1% Eye Drops 45 minutes prior to the injection.

The patients of the third group will receive placebo pill 4 hours and Artificial Tears 45 minutes prior to the injection.

Patients will be required to complete the greek version of the short form McGill Pain Questionnaire (SF-MPQ) comprising of the Visual Analogue Scale, the main component of the SF-MPQ and the Present Pain Intensity Scale immediately after the injection and 6 hours post-IVI.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Pacebo pill and Diclofenac Eye Drops

Pacebo pill will be administered 4 hours before the IVI and one drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.

Group Type: ACTIVE_COMPARATOR

Diclofenac Eye Drops

Intervention Type: DRUG

One drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.

Pacebo pill

Intervention Type: DRUG

Pacebo pill will be administered 4 hours before the IVI.

Oral Diclofenac and Diclofenac Eye Drops

One Diclofenac Sodium sustained-release 75mg tablet administered per os 4 hours prior to the IVI and one drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.

Group Type: ACTIVE_COMPARATOR

Oral Diclofenac

Intervention Type: DRUG

One Diclofenac Sodium sustained-release 75mg tablet administered per os 4 hours prior to the IVI.

Diclofenac Eye Drops

Intervention Type: DRUG

One drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.

Pacebo pill and Artificial Tears

Pacebo pill will be administered 4 hours before the IVI and one drop Artificial Tears will be instilled 45' prior to the IVI.

Group Type: PLACEBO_COMPARATOR

Pacebo pill

Intervention Type: DRUG

Pacebo pill will be administered 4 hours before the IVI.

Artificial Tears

Intervention Type: DRUG

One drop Artificial Tears will be instilled 45' prior to the IVI.

Interventions

Diclofenac Eye Drops

One drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.

Intervention Type: DRUG

Pacebo pill

Pacebo pill will be administered 4 hours before the IVI.

Intervention Type: DRUG

Oral Diclofenac

One Diclofenac Sodium sustained-release 75mg tablet administered per os 4 hours prior to the IVI.

Intervention Type: DRUG

Diclofenac Eye Drops

One drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.

Intervention Type: DRUG

Pacebo pill

Pacebo pill will be administered 4 hours before the IVI.

Intervention Type: DRUG

Artificial Tears

One drop Artificial Tears will be instilled 45' prior to the IVI.

Intervention Type: DRUG

Other Intervention Names

DENACLOF EY.DRO.SOL 0.1% (W/V); VOLTAREN S.R.F.C. 75MG/TAB; DENACLOF EY.DRO.SOL 0.1% (W/V); TEARS NATURALE 0,1%+0,3% EY.DRO.SOL.

Eligibility Criteria

Inclusion Criteria

• All participants will be patients of the Medical Retina Department of our Clinic, who are scheduled to receive IVIs of ranibizumab (Lucentis; Novartis Pharma S.A.S., Huningue, France) or aflibercept (Eylea; Bayer Healthcare Pharmaceuticals, Berlin, Germany) in one eye and had already undergone at least one IVI of an anti-VEGF agent.

Exclusion Criteria

• History of previous eye surgery other than cataract extraction surgery, herpetic eye disease, uncontrolled glaucoma, uveitis, active conjunctivitis, keratitis and bullous keratopathy, a previously known allergic response to diclofenac or other NSAIDs and salicylates, any contraindication to NSAIDs administration such as cardiovascular disease, gastrointenstinal disease with risk of GI ulceration,bleeding and perforation, renal and hepatic disease and any systemic or topical use of NSAIDs or any use of sedative medications within 7 days from the visit and during the day of IVI.
• Patients with poor cooperation in understanding and answering the questions of the SF-MPQ, including the visual analogue scale (VAS).
• Unsuccessful blinding

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

Sponsors

University Hospital of Patras

OTHER

Sponsor Role: lead

Responsible Party

Constantinos D. Georgakopoulos, MD, PhD

Associate Professor of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Constantine Georgakopoulos, MD, Phd

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Ophthalmology, Medical School, University of Patras, Greece

Locations

University Hospital of Patras

Pátrai, Achaea, Greece

Countries

Greece

Other Identifiers

72/2016

Identifier Type: -

Identifier Source: org_study_id