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

NCT ID: NCT02718547

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-26
• Study Completion Date: 2018-07-31

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

Detailed Description

Ocular perfusion pressure (ocular perfusion pressure - OPP), considered the driving force of ocular blood flow. Perfusion pressure is defined as the difference between the artery and vein blood pressure. Because ocular venous pressure is the same or slightly higher than the IOP (intra ocular pressure - IOP), it is common to estimate the OPP as the difference between the arterial blood pressure of IOP. The OPP is critical for diffusion of oxygen, nutrients and metabolic waste from retinal imaging, and decrease it may reduce blood flow to the eye and lead to ischemia or hypoxia. the OPP is controlled by a complex system of Autoregulation. Much has been written about the relationship between the OPP and glaucoma, and agreed that OPP is a low risk factor for this disease.

Diabetic macular edema (DME) is the most common cause of vision loss in developed countries the working-age.

Many studies were carried out in recent years in an attempt to better understand the pathophysiology of Diabetic macular edema, and there is consensus in the scientific literature that hypertension have a significant effect on Diabetic macular edema. this relationship is much more complex than it seems at first glance. Paques and his team have shown an inverse association between blood pressure to drop night and Diabetic macular edema. LARSEN and his team have shown a similar trend.

Hayreh published an article from 2007, where he described the mechanism of improvement of the Diabetic macular edema with discontinuation of hypertensive treatment and thereby raising blood pressure. In this article, Hayreh describes hypoxia as a significant factor in Diabetic macular edema, and demonstrated that treatment of hypoxia by increasing the OPP brought good results in terms of macular thickness If so, it seems that there is not only a link between levels of oxygenation of the retina to Diabetic macular edema, but that improved oxygenation of the retina could lower the levels of macular edema in these patients. If a way were found to improve retinal perfusion, this may lead to an improved oxygenation and reduced edema. The Investigators propose to examine the relationship between macular edema IOP in Participants with Diabetic macular edema, thinking that high IOP means lower OPP, which means increased risk for developing macular edema in this Participants group.

Conditions

Complications of Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Participants receiving Combigan drops in order to reduce IOP

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

Group Type: EXPERIMENTAL

Combigan

Intervention Type: DRUG

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

Interventions

Combigan

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

Intervention Type: DRUG

Other Intervention Names

brimonidine tartrate/timolol maleate ophthalmic solution

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

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

Sponsors

Meir Hospital, Kfar Saba, Israel

OTHER

Sponsor Role: collaborator

Meir Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Avner Belkin

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Meir Medical center

Kfar Saba, Israel, Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Nimrod Dar, MD

Role: CONTACT

nimrod.dar@gmail.com

+972545937757

Facility Contacts

Nimrod Dar, MD

Role: primary

nimrod.dar@gmail.com

+972545937757

References

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Reference Type: BACKGROUND

PMID: 8361399 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20868686 (View on PubMed)

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.

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Reference Type: BACKGROUND

PMID: 8366905 (View on PubMed)

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Reference Type: BACKGROUND

PMID: 7831044 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

PMID: 14744906 (View on PubMed)

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.

Reference Type: BACKGROUND

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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.

Reference Type: BACKGROUND

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Other Identifiers

0029-16-MMC

Identifier Type: -

Identifier Source: org_study_id