Comparison of Treatments in Diabetic Macular Edema

NCT05715385 | Completed Phase 4

• 1 other identifier: 226-31122-142-201800
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Prospective or cohort study to compare the effects of grid macular laser, topical bromfenac 0.09% and placebo (carboxymethyl cellulose 0.5%) medication in diabetic macular edema. 60 eyes with macular edema of two types i.e. cystoid macular edema (CME) and clinically significant macular edema (CSME) were divided into three groups with 20 patients in each group. One group was treated with grid laser photocoagulation, the second group was treated with topical bromfenac 0.09% drops two times a day and the third group was treated with topical carboxy methyl cellulose 0.5% three times a day (placebo treatment).

Conditions

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (3)

• Change in visual acuity in laser photocoagulation group

  Best corrected visual acuity will be measured by logMAR scale

  Baseline and 6 weeks

• Change in visual acuity in bromfenac group

  Best corrected visual acuity will be measured by logMAR scale

  Baseline and 6 weeks

• Change in visual acuity in observation group

  Best corrected visual acuity will be measured by logMAR scale

  Baseline and 6 weeks

Other Outcomes (3)

• Change in central macular thickness in laser photocoagulation group

  Baseline and 6 weeks

• Change in central macular thickness in bromfenac group

  Baseline and 6 weeks

• Change in central macular thickness in observation group

  Baseline and 6 weeks

Study Arms (3)

Laser photocoagulation

ACTIVE COMPARATOR

Grid laser was performed under topical anesthesia with frequency doubled Nd YAG laser of wavelength 532 nm. Laser Parameters for grid photocoagulation Lens used: Mainster grid lens Spot size: 75-100μ The burn intensity for grid laser: barely visible (light grey) Power: 80-100mw depending on the condition of the laser, the opacities in the media and background pigmentation. Duration: 100msec No. of spots: 80-100 Laser burns were placed at least one burn width apart. Wider if the thickening was less severe. If necessary, the grid laser extended up to 2 disc diameters superiorly, inferiorly and temporally from the centre of the macula. Treating the area within 500 microns of the disc margin or the centre of the macula was avoided.

Procedure: laser photocoagulation

Bromfenac 0.09%

ACTIVE COMPARATOR

Twice daily eye drop bromfenac 0.09% for 6 weeks

Drug: eye drop bromfenac 0.09%

Observation

PLACEBO COMPARATOR

Eye drop carboxymethyl cellulose 0.5% to be instilled thrice a day for 6 weeks

Drug: Placebo

Interventions

laser photocoagulation PROCEDURE

Laser Parameters of grid photocoagulation Diffuse diabetic macular edema is treated by a grid pattern of laser. The grid is applied to areas of retinal thickening with diffuse leakage or capillary non-perfusion. Spot size: 50-100 micron is utilized. The burn intensity for grid laser: barely visible (light grey). Power of laser burn is between 80-100 mw depending on the condition of the laser, the opacities in the media and background pigmentation. Laser burns should be placed at least one burn width apart, wider if thickening is less severe. If necessary, the grid can extend up to 2 disc diameters superiorly, inferiorly, and temporally from the centre of the macula. One should avoid treating within 500 microns of the disc margin or the centre of the macula. Duration of about 0.05-0.1 sec is used Number of spots- 100-500

Laser photocoagulation

eye drop bromfenac 0.09% DRUG

twice daily e/d bromfenac 0.09% for 6 weeks

Bromfenac 0.09%

Placebo DRUG

Observation group. No intervention done. Only eye drop carboxymethyl cellulose 0.5% to be instilled thrice a day for 6 weeks.

Observation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with type 1 or type 2 diabetes.
• The study eye met the following:
• OCT thickness of the macula upto 400 microns.
• On clinical examination, definite retinal thickening due to diabetic macular edema within 3000 μm of the center of the macula.
• Patient with well controlled blood sugar levels i.e. fasting blood sugar level \< 110mg% and post prandial blood sugar level \< 126 mg%. Also HbA1c level less than 7%.
• Able and willing to provide informed consent.
• Media clarity, pupillary dilation, and study participant cooperation sufficient for adequate OCT and fundus photographs.
• Normal optic disc.

You may not qualify if:

• Use of systemic corticosteroids for any other systemic condition or previous anti-Vascular endothelial growth factor (VEGF) therapy.
• Current use of prescription systemic NSAIDs.
• Known allergy to bromfenac.
• History of use of NSAID eye drops within the last 30 days or anticipated need for such drops during the study due to other ocular conditions.
• Any ocular condition, coexisting with diabetic macular edema, which might affect visual acuity.

Sponsors & Collaborators

• Babasaheb Ambedkar Memorial Hospital: lead

Related Publications (6)

• Pinna A, Blasetti F, Ricci GD, Boscia F. Bromfenac eyedrops in the treatment of diabetic macular edema: a pilot study. Eur J Ophthalmol. 2017 May 11;27(3):326-330. doi: 10.5301/ejo.5000888. Epub 2016 Nov 16.

  PMID: 28009414 BACKGROUND

• Busch C, Fraser-Bell S, Zur D, Rodriguez-Valdes PJ, Cebeci Z, Lupidi M, Fung AT, Gabrielle PH, Giancipoli E, Chaikitmongkol V, Okada M, Lains I, Santos AR, Kunavisarut P, Sala-Puigdollers A, Chhablani J, Ozimek M, Hilely A, Unterlauft JD, Loewenstein A, Iglicki M, Rehak M; International Retina Group. Real-world outcomes of observation and treatment in diabetic macular edema with very good visual acuity: the OBTAIN study. Acta Diabetol. 2019 Jul;56(7):777-784. doi: 10.1007/s00592-019-01310-z. Epub 2019 Mar 22.

  PMID: 30903434 BACKGROUND

• Baklayan GA, Munoz M. The ocular distribution of (14)C-labeled bromfenac ophthalmic solution 0.07% in a rabbit model. Clin Ophthalmol. 2014 Sep 4;8:1717-24. doi: 10.2147/OPTH.S66638. eCollection 2014.

  PMID: 25228788 BACKGROUND

• Schoenberger SD, Kim SJ. Nonsteroidal anti-inflammatory drugs for retinal disease. Int J Inflam. 2013;2013:281981. doi: 10.1155/2013/281981. Epub 2013 Jan 14.

  PMID: 23365785 BACKGROUND

• Waterbury LD, Silliman D, Jolas T. Comparison of cyclooxygenase inhibitory activity and ocular anti-inflammatory effects of ketorolac tromethamine and bromfenac sodium. Curr Med Res Opin. 2006 Jun;22(6):1133-40. doi: 10.1185/030079906X112471.

  PMID: 16846546 BACKGROUND

• Ahmadi MA, Lim JI. Update on laser treatment of diabetic macular edema. Int Ophthalmol Clin. 2009 Spring;49(2):87-94. doi: 10.1097/IIO.0b013e31819fd6b2. No abstract available.

  PMID: 19349789 BACKGROUND

Study Officials

• Mehul Joshi, FRCS,DNB

  Dr Babasaheb Ambedkar Central Railway Hospital, Byculla, Mumbai, Maharashtra, India

  PRINCIPAL INVESTIGATOR

• Arundhati Malviya, MS(Ophthal)

  Dr Babasaheb Ambedkar Central Railway Hospital, Byculla, Mumbai, Maharashtra, India

  STUDY CHAIR

• Memuna Bahadur, MS(Ophthal)

  Dr Babasaheb Ambedkar Central Railway Hospital, Byculla, Mumbai, Maharashtra, India

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 8, 2023
• Study Start: November 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be submitted for publication in the Indian Journal of Ophthalmology after approval by the clinicialtrials.gov registration department and will be available there always for reference.
• Access Criteria: Keywords to access the study will be Diabetic macular edema; Bromfenac; Laser photocoagulation