Launch of a new alliance for global assessment of diabetic retinopathy

A new project has been launched to assess the awareness, treatment and implications of diabetic retinopathy globally. Results are intended to inform decision-making and policy development around this common and serious complication of diabetes.

Project partners, the International Federation on Ageing (IFA) and the International Diabetes Federation (IDF), working in collaboration with the New York Academy of Medicine (NYAM) and the International Agency for the Prevention of Blindness (IAPB) will gather evidence on knowledge, policies, standards of care, and supportive services for retinopathy across 40 countries.

Retinopathy is one of the most common complications associated with diabetes and one of the major causes of adult blindness. Up to 11% of adults with diabetes have Diabetic Macular Edema (DME), a specific type of diabetic retinopathy. According to the IDF Diabetes Atlas 6^th edition, there are large variations in the estimates of retinopathy prevalence in people with known diabetes, with estimates ranging from 11 to 45% worldwide in people with type 1 and type 2 diabetes.

The global assessment of retinopathy has two substantive and connected phases:

1. Phase I comprises approximately 120 interviews in eight countries representative of low, middle and high socio-economic status to better understand the level of awareness of: retinopathy as a condition and common complication of diabetes; the access, availability and pathway to retinopathy services; and the existence and content of relevant governmental policy.

2. Phase II is the implementation of a survey in 40 countries, which will be formulated based on the data gathered in Phase I. The survey aims to garner statistically significant evidence intended to assist in the development of effective governmental policy.

The project will culminate in the production of a barometer report and a compendium of resources designed to increase awareness, as well as to inform policy and practice related to diabetic retinopathy and vision loss across countries.

This project is financially supported by Bayer Pharma AG. Bayer is not involved in the analysis of the findings.

Source

Mum with ROP manages with a guide dog

Wendy Wright thought she was exceedingly clumsy in her early adulthood. The 49-year-old has managed her condition, known as Retinopathy of Prematurity (ROP), for decades, but now has a new-found freedom thanks to guide dog, Freya.

The mum of five has no peripheral vision, a result of her premature birth.

Ms Wright has had Freya (3) for six months and said it was “amazing” how much of a difference the dog had made to her life.

Freya and Ms Wright graduated as a guide dog team on Tuesday.

from www.inmycommunity.com.au

Ms Wright, manager of the |Needle and Syringe Exchange Program, commutes to work in the Perth CBD by public transport with Freya every morning.

“I can walk down the street, turn my head and look into a shop window without walking into the back of someone, if there’s a person there Freya will guide me around them,” she said.

“I had so much trouble using a white cane, I’d walk into people with their iPod headphones in and they’d get annoyed.

“She’s also taken it upon herself to be my companion, which I didn’t expect, I had some very bad news recently and she didn’t leave my side – that bond after six months just amazes me.”

In 2013 the Association for the Blind, which runs Guide Dogs WA, celebrates 100 years of service to the WA community.

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FDA Requests More Trials of Retinal Disease Treatment

Alimera Sciences, Inc., a biopharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, today announced that it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) in response to the New Drug Application (NDA) for ILUVIEN® for the treatment of diabetic macular edema (DME) associated with diabetic retinopathy.

A CRL is issued by the FDA's Center for Drug Evaluation and Research when their review of an application is completed and questions remain that precludes the approval of the NDA in its current form.

Alimera is seeking approval for Iluvien as a treatment for diabetic macular edema, a condition that can cause blurred vision and blindness.

The FDA stated that it was unable to approve ILUVIEN because there was no provide sufficient data to support that ILUVIEN is safe and effective in the treatment of patients with DME. The FDA stated that the risks of adverse reactions shown for ILUVIEN in the FAME® Study were significant and were not offset by the benefits demonstrated by ILUVIEN in these clinical trials. The FDA has indicated that Alimera will need to conduct two additional clinical trials to demonstrate that the product is safe and effective for the proposed indication.

The company officials will request a meeting with the FDA to clarify its next steps. 

ILUVIEN is Alimera's investigational, sustained drug delivery system that releases sub-microgram levels of fluocinolone acetonide (FAc) for the treatment of DME.

Alimera initially had asked the FDA to approve Iluvien in June 2010. In December, the FDA asked the company to report data from a third year of a clinical trial, and Alimera filed that data in May 2011. It also responded to the agency's concerns about manufacturing, packaging and sterilization of the drug. 

In December 2010, the FDA issued a CRL to Alimera related to its June 2010 NDA for ILUVIEN, which included data through month 24 of the FAME™ Study.

In that first CRL, the FDA asked for, among other things, analyses of the safety and efficacy data through month 36 of the FAME Study. Alimera submitted a response to the FDA on May 12, 2011, addressing the issues raised in the first CRL and including 36-month trial data. The FDA classified Alimera's response as a Class 2 resubmission, resulting in a six-month review period and a Prescription Drug User Fee Act, or PDUFA, date of November 12, 2011.

For Europe, Alimera expects to submit its formal response to the Preliminary Assessment Report to the Medicines and Healthcare products Regulatory Agency (MHRA) later this month. Based on this submission, the MHRA is expected to make a recommendation on the approvability of ILUVIEN to Alimera and the Concerned Member States (Austria, France, Germany, Italy, Portugal and Spain) by the end of this year, with a decision regarding the approval of ILUVIEN expected in the first half of 2012. The market opportunity in Europe is similar in size to the U.S. market opportunity.

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Is there a connection between pregnancy, diabetes and diabetic retinopathy?

- Shveta Garg, Pune, India

Diabetes refers to a condition in which the body cannot adequately use the sugars and starches (carbohydrates) it takes in as food to make energy. The body either makes too little insulin in the pancreas, or the insulin it makes is not sufficient to change those sugars and starches into energy. As a result, the body collects extra sugar in the blood. This extra sugar, if allowed to collect in the body for too long, can damage organs such as the heart, eyes and kidneys.

Three types of diabetes are known: Type 1, Type 2, and Gestational (pregnancy-related). Type 1 is due to lack of insulin in the body, while resistance to action of insulin leads to Type 2. This article discusses the connection between pregnancy and diabetes.

Diabetes is often detected in women during their childbearing years and can affect the health of both the mother and her unborn child. Diabetes and fertility are also related. Young women with diabetes, either Type 1 or 2, tend to start their periods a little bit later in life than women without diabetes. On the other end of the spectrum, women with diabetes tend to go through menopause slightly earlier, so this provides a slightly smaller window of fertility for them. In addition, many women with Type 2 diabetes have an underlying syndrome called 'polycystic ovarian disease, in short referred to PCOD. Because of the effects of PCOD on the ovaries, women with Type 2 diabetes and PCOD may take longer to conceive than women without diabetes.

Now, if a woman has diabetes, and wants to get pregnant, it is critically important for her to be in good control of her blood glucose levels before she goes off any contraceptive agents, and starts trying to get pregnant. It is a good idea to be in good blood glucose control three to six months before she conceives. Also, the blood glucose levels should be kept under control during pregnancy and, of course, after as well.

The early weeks of pregnancy are important for the baby. Since most women do not know of their pregnancy until the baby has been growing for about two to four weeks, one needs to really plan the pregnancy. Also, a treatment plan has to be put in place to balance meals, exercise & intake of insulin. This plan will, of course, change as the pregnancy progresses as per the recommendations of your doctor and a dietician. You will also need to check your blood glucose often, and keep a record of your results. With your blood glucose in the target range and good medical care, the chances of a trouble-free pregnancy and a healthy baby are almost as good as they are for a woman without diabetes

Pregnancy in women with pre-existing diabetes is generally considered to be high-risk. It does not necessarily mean problems, but your doctor may have to work with other specialists to help you have a healthy pregnancy and baby.

Gestational diabetes is a type of diabetes that is first diagnosed in a pregnant woman. It can often be controlled by a proper diet and regular exercise regimen alone, but sometimes a woman with gestational diabetes may need to take medications. In most cases, this condition goes away after pregnancy. Many women who have had gestational diabetes have an increased chance of developing Type 2 diabetes later, but with healthy diet, regular exercise and weight control, it can be delayed or prevented completely.

If a woman has medical conditions caused by her diabetes, pregnancy can make these conditions worse. Miscarriage and stillbirth are more common in pregnant women with diabetes. Hence the need to be cautious.

After delivery, it is as important to keep check on blood glucose level as it was during pregnancy. Some new mothers have better blood glucose control in the first few weeks after delivery, while for most, it is a period of fluctuating blood glucose level. During the first few weeks at home with the baby, most mothers are tired and stressed from lack of sleep, and with odd sleep patterns, the chances of napping at mealtime or snack time increase, which can potentially cause a dangerous lowering of blood glucose. It is important to check your blood glucose level often during this time, to avoid blood glucose reactions that may not be good for the baby or the mother. Breastfeeding is equally good for women with diabetes, but it may make your blood glucose a little harder to predict. To help prevent low blood glucose levels during breastfeeding, it is a good idea to have a snack, water or a caffeine-free drink at frequent intervals.

Diabetic retinopathy is referred to retinal damage caused by complications of diabetes mellitus, which may eventually lead to blindness. Diabetic retinopathy is one of the major causes of preventable blindness around the world in those aged between 24 and 64 years. For a significant number of diabetic women, the first half of this period coincides with peak fertility and childbearing years. Diabetic eye disease may develop for the first time during pregnancy, and visual loss at this stage can have serious implications for both the patient and her family.

Several studies on the progression of diabetic retinopathy in women have tried to explain if it is the natural tendency of the disease, or some unique factors that operate during pregnancy, which cause deterioration. That retinopathy worsens during pregnancy is now undisputed, although the mechanism by which progression occurs depend on a variety of factors. The major factors influencing progression of retinopathy during pregnancy include; the state of pregnancy itself, duration of diabetes prior to the pregnancy, degree of retinopathy at time of conception, metabolic control before and during pregnancy, as well as the presence of coexisting hypertension.

There are certain recommendations that are widely accepted for the management of diabetic patients with retinopathy who are planning pregnancy or are already pregnant. Since the risk of progression of retinopathy during pregnancy is greater in women who have had diabetes for longer periods of time, it is beneficial to counsel women in their childbearing years about planning their pregnancies early if possible.

When planning pregnancy, women with preexisting diabetes should have a comprehensive eye examination and should be aware of the risk of development and/or progression of diabetic retinopathy. Women with diabetes who become pregnant should have the eye examination in the first trimester, and close follow-up throughout life.

Pregnancy in a diabetic woman brings about many changes that can lead to the development of diabetic retinopathy or worsening of pre-existing disease. In some patients this may develop into sight threatening disease which, if not treated adequately, can cause devastating visual impairment.

If you wish to read more on the above topic, please click here, here, here, here or here.

Revised blood sugar levels may predict development of retinal disease in patients with Diabetes

New hyperglycemia thresholds may predict the onset of retinopathy more accurately than the standard benchmarks in patients with diabetes mellitus, a study has found.

The current definition of diabetes is a fasting plasma glucose (FPG) level of 126 mg/dL or higher.

"We propose that thresholds of 108 mg/dL for FPG, and concentration of 6% for [hemoglobin A1C] level could be used to define those who are at risk of retinopathy," the study authors said.

The Data From an Epidemiological Study on Insulin Resistance Syndrome Study included 700 patients, ranging in age from 30 to 65 years. The patients were recruited between 1994 and 1996, and underwent health examinations at 3, 6 and 9 years after enrollment.

At 9 years, 235 patients had been treated for diabetes or had FPG levels of 126 mg/dL or higher, 227 patients had an impaired fasting glucose level of 110 mg/dL to 125 mg/dL at least once, and 238 patients had glucose levels lower than 110 mg/dL.

A non-mydriatic digital retinal camera was used to obtain high-resolution retinal images at 10 years. Retinopathy was identified in 44 patients.

Study results showed that patients with retinopathy had a mean baseline FPG level of 130 mg/dL and hemoglobin A1C level of 6.4%. Patients without retinopathy had a mean baseline FPG of 106 mg/dL and hemoglobin A1C level of 5.7%. Both differences were statistically significant (P < .001).

An FPG level of 108 mg/dL had a positive predictive value of retinopathy at 10 years of 8.4% and a level of 116 mg/dL had a predictive value of 14%.

A hemoglobin A1C level of 6% had a positive predictive value of 6% and a level of 6.5% had a predictive value of 14.8%, the authors reported.

For those who want to read the abstract or the paper, please click here.

Treatment for severe form of Retinopathy of Prematurity (ROP)

A study from Iran has shown that an injection of bevacizumab (or Avastin) injection into the eye of a baby with severe form of Retinopathy of Prematurity (ROP) may be effective for treating such cases that are associated with significant bleeding in the eye. 

The study enrolled 14 eyes of eight premature infants, all of whom had one or two sessions of laser treatment and were given injection of Avastin (bevacizumab by Genentech Company) immediately after diagnosis of bleeding or hemorrhage in the eye. Follow-up examinations were conducted at 1, 3, 7 and 14 days and 1, 2 and 3 months after injection. Plus disease (which is one of the severe stages of ROP) started to subside 1 day to 3 days after injection, and disappeared completely in all eyes within 2 weeks. At final follow-up, all eyes were stable with attached retinas and normal appearing blood vessels in the retina. 

Avastin, a drug that has shown significant treatment potential in various retinal conditions, including age-related macular degeneration, diabetic retinopathy, retinopathy of prematurity, vasicular occlusions, and even some conditions in patients with retinitis pigmentosa, has been shown to be effective in the severe forms of retinopathy of prematurity patients. Previously, such patients were treated with extensive laser sessions, which was difficult to treat in eyes with bleeding, since laser treatment cannot be performed in eyes with blood. Such babies had to be followed up significantly every few days to check for any evidence of progression of the disease. Considering that these are premature babies, usually in a neonatal intensive care unit, and some of them with other medical problems, such follow-up exams are usually very stressful for everyone involved; the infant baby, the neonatologist and the retina specialist who is examining and treating the baby. Hence, having an additional treatment significantly helps a retinal specialist.

Ref: Graefes Arch Clin Exp Ophthalmol. 2010 Dec;248(12):1713-8. Epub 2010 Jun 27.

Welcome to Retina India

Retina India is a not-for-profit organization, registered with the Charity Commissioner, Mumbai, India, established for empowering people with retinal disorders, and bringing them and their families on a common platform with physicians, researchers, counselors, low vision and mobility experts and other specialists.

Why do we need another not-for-profit organization?

India is home to approximately 24 million blind people, the largest in the world. Additionally, there are another 52 million visually impaired in the country. It is thought that if this trend is allowed to continue, the number of blind people would increase to 31.6 million by 2020.

The blindness-prevention programs that are sponsored by governmental agencies and by non governmental organizations (NGOs) usually focus on "avoidable" or "preventable" blindness that commonly includes cataract and corneal problems. Even though patients with preventable blindness in India are significant, the prevalence of retinal ailments, such as retinitis pigmentosa and allied disorders, macular degeneration, diabetic retinopathy, etc. is gradually increasing. Some of these diseases do not even have a cure at this time, and usually leave the affected people with permanent visual impairment for a lifetime. There has been no singular effort in India to unite the efforts in the fields of medical research, education, rehabilitation and welfare of people with retinal disorders.

It is this void that Retina India aims to fill.

Retina India is focused on spreading awareness amongst society, the NGOs and the Governmental agencies about people with retinal ailments and the specific issues they and their families face. We also wish to help them make a difference to their own lives, and to the lives of people around them.

Our Vision

To empower patients and families of patients with retinal ailments, and help them make a significant contribution to their own lives, and to the lives of people around them.

Our Mission

To increase awareness of retinal diseases and champion the cause of people who get affected by them, and to induce increased research efforts towards treatment for such diseases.
Our people

Simply said, Retina India is a movement, It is a movement that includes all of you. It is our strong belief that when people come together, and work towards a common cause, a lot can get done.

Retina India includes patients with retinal disorders and their families. It also includes retinal specialists and other ophthalmologists with an interest in retinal diseases, low vision experts, mobility experts, counselors, and others. We invite people with a social spirit, who have an inherent desire to do something good for others, and make a difference in someone's life, to volunteer and be a part of this movement. We also invite young adults, school and college students, to gain experience in working on a project for Retina India .

Our Key Objectives:

Patient Alliance: The alliance brings together patients with retinal disorders, along with their families and friends, to work for mutual benefit.

Medical Research and Treatments: Retina India highlights, coordinates and sponsors research in retinal treatment in India, while also informing the patients and their families about the current on-going research in India and around the world.

Clinical trials in India: We act as a channel to bring new treatments and technologies to India (Gene Therapy, Artificial Retina, Stem-Cell treatment, etc.) for Indian patients with retinal disorders.

Patient Registry: Retina India maintains databases (or registries) of patients with specific retinal diseases. Such registries will help inform patients likely to benefit from new treatments, such that they are not left to wonder whether a new treatment is beneficial to them or not, and in the process, spend a lot of time, effort and money in finding that out. Registries for Retinitis Pigmentosa, Macular Degeneration, Retinopathy of Prematurity, Leber's Congenital Amaurosis, etc. are already functional.

Education, Counseling & Advocacy: Activities range from encouraging beneficiaries to pursue their lives productively, counseling them about education, employment, marriage and family issues, to rehabilitation, independence training and mobility skills via associations with other organizations in the country. We are also commited to advocacy about the concerns of people with retinal ailments.

We welcome you to make a difference in your own life, and in the lives of people around you.