The Relationship Between Intraocular Pressure and Macular Edema in Patients With Diabetic Macular Edema

NCT02718547 | Unknown DMC

• 1 other identifier: 0029-16-MMC
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The Investigators propose to examine the effect of lowering the intraocular pressure on macular edema in Participants diagnosed with diabetic macular edema. Our theory is based on the assumption that lower intraocular pressure means higher Ocular Perfusion pressure, which may cause an improvement in retinal perfusion and thus an improvement in retinal oxygenation and reduced edema

Conditions

Complications of Diabetes Mellitus

Keywords

Diabetes mellitus; Diabetic macular edema; Intra ocular pressure; Ocular perfusion pressure; Retinal perfusion

Outcome Measures

Primary Outcomes (1)

• Change of at least 50 micron in Macular edema

  The participants will be examined every month from the time of recruitment as mentioned before, at each visit the Macular Edema will be assessed, but the Outcome measure will be defined as Change of at least 50 Micron in Macular Edema at the third visit, 3 months from recruitment

  Baseline measurement will be conducted at the recruitment of the participant, the second measurement will be preformed after one moth from recruitment and the third and last measurement will be preformed after 3 months from recruitment

Study Arms (1)

Participants receiving Combigan drops in order to reduce IOP

EXPERIMENTAL

All of the Participants in this study will be instructed to instill combigan eye drops twice daily in one eye (randomly chosen)

Drug: Combigan

Interventions

Combigan DRUG

Each Participant will be instructed to instill Combigan eye drops twice daily in one of his eyes (randomly chosen)

Also known as: brimonidine tartrate/timolol maleate ophthalmic solution

Participants receiving Combigan drops in order to reduce IOP

Eligibility Criteria

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

You may qualify if:

• Participants with a diagnosis of diabetic macular edema over the age of 18 which are eligible to sign an agreement to participate in the study
• Presence of DME (based on clinical examination of retinal specialist + OCT) in both eyes with an edema thickness ranged from 350 to 800 microns
• Media lucid enough to allow sufficient quality photographs by OCT

You may not qualify if:

• Patients which do not have a valid diagnosis of DME (Diabetic Macular Edema)
• Patients with problems that can cause macular edema in any other:
• Age-Related Macular Degeneration
• Central retinal vein occlusion (CRVO)/Branch retinal vein occlusion (BRVO) /central retinal artery occlusion (CRAO) / branch retinal artery occlusion (BRAO)
• Epiretinal membrane (ERM) or Vitreo-macular traction (VMT)
• Patients who are Pseudophakic in one eye or pseudophakic in both eyes for less than a year
• Patients treated in order to reduce the DME by intra-vitreal injection or by laser in the past six months
• Patients which are currently treat with Intra ocular Pressure lowering drops in at least one eye, or have been treated in the past with laser of any kind or with surgery
• Patients who underwent Pars plana vitrectomy one or both eyes
• Patients who cannot undergo an OCT examination
• Patients who want prefer to be treated by the current practices based on clinical judgment
• Patients with a condition that requires an intervention or laser surgery during the 3 months of study, such as active Proliferative diabetic retinopathy, vitreous hemorrhage or other similar conditions

Sponsors & Collaborators

• Meir Medical Center: lead
• Meir Hospital, Kfar Saba, Israel: collaborator

Study Sites (1)

Meir Medical center

Kfar Saba, Israel, 69419, Israel

RECRUITING

Related Publications (14)

• Glucksberg MR, Dunn R. Direct measurement of retinal microvascular pressures in the live, anesthetized cat. Microvasc Res. 1993 Mar;45(2):158-65. doi: 10.1006/mvre.1993.1015.

  PMID: 8361399 BACKGROUND

• Schmidl D, Garhofer G, Schmetterer L. The complex interaction between ocular perfusion pressure and ocular blood flow - relevance for glaucoma. Exp Eye Res. 2011 Aug;93(2):141-55. doi: 10.1016/j.exer.2010.09.002. Epub 2010 Sep 22.

  PMID: 20868686 BACKGROUND

• Thomas BJ, Shienbaum G, Boyer DS, Flynn HW Jr. Evolving strategies in the management of diabetic macular edema: clinical trials and current management. Can J Ophthalmol. 2013 Feb;48(1):22-30. doi: 10.1016/j.jcjo.2012.11.012.

  PMID: 23419295 BACKGROUND

• Lasker RD. The diabetes control and complications trial. Implications for policy and practice. N Engl J Med. 1993 Sep 30;329(14):1035-6. doi: 10.1056/NEJM199309303291410. No abstract available.

  PMID: 8366905 BACKGROUND

• Klein R, Klein BE, Moss SE, Cruickshanks KJ. The Wisconsin Epidemiologic Study of Diabetic Retinopathy. XV. The long-term incidence of macular edema. Ophthalmology. 1995 Jan;102(1):7-16. doi: 10.1016/s0161-6420(95)31052-4.

  PMID: 7831044 BACKGROUND

• Bhagat N, Grigorian RA, Tutela A, Zarbin MA. Diabetic macular edema: pathogenesis and treatment. Surv Ophthalmol. 2009 Jan-Feb;54(1):1-32. doi: 10.1016/j.survophthal.2008.10.001.

  PMID: 19171208 BACKGROUND

• Matthews DR, Stratton IM, Aldington SJ, Holman RR, Kohner EM; UK Prospective Diabetes Study Group. Risks of progression of retinopathy and vision loss related to tight blood pressure control in type 2 diabetes mellitus: UKPDS 69. Arch Ophthalmol. 2004 Nov;122(11):1631-40. doi: 10.1001/archopht.122.11.1631.

  PMID: 15534123 BACKGROUND

• Paques M, Massin P, Sahel JA, Gaudric A, Bergmann JF, Azancot S, Levy BI, Vicaut E. Circadian fluctuations of macular edema in patients with morning vision blurring: correlation with arterial pressure and effect of light deprivation. Invest Ophthalmol Vis Sci. 2005 Dec;46(12):4707-11. doi: 10.1167/iovs.05-0638.

  PMID: 16303968 BACKGROUND

• Larsen M, Wang M, Sander B. Overnight thickness variation in diabetic macular edema. Invest Ophthalmol Vis Sci. 2005 Jul;46(7):2313-6. doi: 10.1167/iovs.04-0893.

  PMID: 15980216 BACKGROUND

• Hayreh SS. Role of retinal hypoxia in diabetic macular edema: a new concept. Graefes Arch Clin Exp Ophthalmol. 2008 Mar;246(3):353-61. doi: 10.1007/s00417-007-0678-2. Epub 2007 Sep 18.

  PMID: 17876597 BACKGROUND

• Vinten M, La Cour M, Lund-Andersen H, Larsen M. Acute effect of pure oxygen breathing on diabetic macular edema. Eur J Ophthalmol. 2012 Aug 8:0. doi: 10.5301/ejo.5000195. Online ahead of print.

  PMID: 22890599 BACKGROUND

• Nguyen QD, Shah SM, Van Anden E, Sung JU, Vitale S, Campochiaro PA. Supplemental oxygen improves diabetic macular edema: a pilot study. Invest Ophthalmol Vis Sci. 2004 Feb;45(2):617-24. doi: 10.1167/iovs.03-0557.

  PMID: 14744906 BACKGROUND

• Vinten M, la Cour M, Lund-Andersen H, Larsen M. Effect of acute postural variation on diabetic macular oedema. Acta Ophthalmol. 2010 Mar;88(2):174-80. doi: 10.1111/j.1755-3768.2008.01421.x. Epub 2009 Dec 13.

  PMID: 19094166 BACKGROUND

• Frederiksen CA, Jeppesen P, Knudsen ST, Poulsen PL, Mogensen CE, Bek T. The blood pressure-induced diameter response of retinal arterioles decreases with increasing diabetic maculopathy. Graefes Arch Clin Exp Ophthalmol. 2006 Oct;244(10):1255-61. doi: 10.1007/s00417-006-0262-1. Epub 2006 Mar 15.

  PMID: 16538448 BACKGROUND

MeSH Terms

Conditions

Diabetes Complications; Diabetes Mellitus

Interventions

Brimonidine Tartrate, Timolol Maleate Drug Combination; Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Timolol; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Combinations; Pharmaceutical Preparations

Central Study Contacts

Nimrod Dar, MD

CONTACT

+972545937757; nimrod.dar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 6, 2016
• First Posted: March 24, 2016
• Study Start: March 26, 2017
• Primary Completion: March 30, 2018
• Study Completion: July 1, 2018
• Last Updated: March 28, 2017

Record last verified: 2017-03

Locations

IL (1)