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What is Clinical Trial?

A clinical trial involves research study on human volunteers that is designed to add medical knowledge to improve health and also helps to determine the safety and efficacy of the proposed new treatment.

Medical knowledge is related to new treatment, diagnostics techniques, medical devices etc.

Phase I Trial

They are usually small trials, investigational medicine or product tested in small group Main aims are to find out:

• Drug doses range
• Medication Efficacy
• Medication side effects

Phase 2 Trial (Phase II)

Investigational medicine or product tested in approximately 100 to 500 volunteers\ Main aims are to find out:

• Effectiveness of investigational product
• More about side effects and how to manage them
• Determine optimal dose

Phase 3 Trial (Phase III)

Investigational medication or product tested in large number of volunteers approximately 1000 to 500 volunteers The main aims are to find out:

• Confirm the Effectiveness of investigational product
• To identify and monitor adverse event (side effects)

Phase 4 Trial (Phase IV)

Phase 4 trials are done after investigational product has been granted a license. The main aims are to find out:

• More details about the effectiveness and safety
• To identify the long term risks and benefits are

Clinical Trials for Year 2014-2015

UNraveling nAMD real life Clinical management and Outcome with intraVitrEal Ranibizumab injection – A retrospective analysis (UNCOVER) Current Status: Completed

A Prospective, Comparative, Assessor Blind, Randomized, Multicenteric Phase III study to compare the safety and efficacy of Ranibizumab of Intas Biopharmaceuticals Ltd. in comparison with Lucentis of Novartis in patients of wet AMD (Age related Macular Degeneration) Current Status: Ongoing

A phase II, randomized, double-masked, sham controlled trial of qpi-1007 delivered by multi-dose Intravitreal injections to subjects with acute non Arteritic anterior ischemic optic neuropathy (NAION). Current Status: Ongoing

A 12-month, phase III, randomized, double-masked, multicenter,active-controlled study to evaluate the efficacy and safety of two individualized regimens of 0.5 mg ranibizumab vs. verteporfin PDT in patients with visual impairment due to choroidal neovascularization secondary to pathologic myopia (Brilliance). Current Status: Ongoing

Completed Clinical Trials:

Sponsor: Karmic Life Sciences (Mulund) Ocular hypertension or mild open angle glaucoma

Sponsor: Allergan (Bangalore) Retinal Detachment

Sponsor: Quintiles (Bangalore) Adenoviral Conjunctivitis

Sponsor: Allergan Glaucoma and Ocular Hypertension

Sponsor: Omnicare Active Non-Infectious Uveitis of the Intermediate or Posterior Segments of the Eye

Sponsor: Kendle Diabetic macular edema (DME)

Sponsor: Kendle Neovascular age-related macular degeneration (AMD)

Sponsor: Novartis Choroidal neovascularization secondary to pathologic myopia

Sponsor: Regeneron Diabetic Macular Edema

Sponsor: Max Neeman Bacterial Conjunctivitis

Sponsor: Lambda Ocular inflammation and infection associated with blepharaconjunctivitis

Sponsor: Quintiles Adenoviral Conjunctivitis

Stem Cell Culture Project :

The retinal pigment epithelium (RPE) plays a key role in maintaining retinal function. Retinal degenerations and dystrophies are the major causes of genetically inherited blindness in the developed world. Photoreceptor replacement in the form of a cell-based therapeutic approach might possibly aid in the restoration of some degree of vision. In this respect, if an accessible pluripotent stem cell source can be identified; autologous stem cell therapies offer a great advantage.

Retina

The retina is very thin layer of tissue that kines the inner part of the eye. It is responsible for capturing light rays that enter the eye much like a camera film's role in photography. These light impulses are then sent to the brain for processing, via the optic nerve. Fifty percent of all blindness is caused by damage to the retina, diabetic retinopathy being one of the major culprits. Almost 10 million people world-wide are blind as a result of Age-related Macular Degeneration (AMD) and Retinitis Pigmentosa (RP).

 What is Retinitis Pigmentosa?

Retinitis pigmentosa (RP) is the name given to a group of inherited eye diseases that affect the retina. RP causes the degeneration of photoreceptor cells in the retina. Photoreceptor cells capture and process light helping us to see. As these cells degenerate and die, patients experience progressive vision loss RP symptoms can vary. In a person with classic or typical RP, night vision and peripheral (or side) vision will be affected initially. Night blindness is one of the earliest and most frequent symptoms of RP. The loss of peripheral vision is often called tunnel vision. If you imagine peering down a tunnel, able only to see what is in front of you and nothing to the side, this is what it is like to lose peripheral vision. As vision loss progresses, the tunnel becomes more and more narrow. In the later stages some patients may also lose central vision. What is common to all cases of RP is the progressive nature of the disease. Not much is known about the cause of retinitis pigmentosa, except that it is inherited or a parent will be a carrier. Other forms of RP and related diseases include Usher syndrome, Leber’s congenital amaurosis, rod-cone disease, and Bardet-Biedl syndrome, among others.

(Signs and Symptoms)
• Since retinitis pigmentosa begins as rod degeneration, the patient first notices increasing difficulty in night vision, followed by difficulty seeing in the periphery. Slowly progressive constriction of the visual field leads to tunnel vision.
• A small area of central vision in both eyes usually persists for years.
• Later on, central vision may also get affected, making detailed work like reading or threading a needle difficult.
• You may also see small shimmering flashes of light (called photopsia).
• Generally night blindness precedes tunnel vision by years or even decades. Total blindness eventually ensues in most cases. The age of appearance of legal blindness ranges from as early as childhood to as late as the 40s

What is the treatment for retinitis pigmentosa?

• As of now there is no specific cure for retinitis pigmentosa. For years, vitamin A therapy has been recommended for many RP patients, based on research dating back to the early 1990s.

Vitamin A, Omega 3 rich diet may be beneficial. Sunglasses should be used to protect the retina from the damaging effects of UV light.

Recent Research Advances in Retinitis Pigmentosa

1) Argus II Retinal Prosthesis System:
The Argus® II Retinal Prosthesis System (“Argus II”) is also known as the bionic eye or the retinal implant. It is intended to provide electrical stimulation of the retina to induce visual perception in blind individuals. It is indicated for use in patients with severe to profound retinitis pigmentosa. A miniature video camera housed in the patient’s glasses captures a scene. The video is sent to a small patient-worn computer (i.e., the video processing unit – VPU) where it is processed and transformed into instructions that are sent back to the glasses via a cable. These instructions are transmitted wirelessly to an antenna in the retinal implant. The signals are then sent to the electrode array, which emits small pulses of electricity. These pulses bypass the damaged photoreceptors and stimulate the retina’s remaining cells, which transmit the visual information along the optic nerve to the brain, creating the perception of patterns of light. Patients learn to interpret these visual patterns with their retinal implant

The Argus II was approved by the Food and Drug Administration in February 2013. It was developed by Second Sight Medical Products, Inc. and is now offered at the University of Michigan Kellogg Eye Center, one of 13 major centers across the country to offer the implant.

How Is Argus® II Designed To Produce Sight?

In a healthy eye, the photoreceptors (rods and cones) in the retina convert light into tiny electrochemical impulses that are sent through the optic nerve and into the brain, where they are decoded into images. If the photoreceptors no longer function correctly—due to conditions such as retinitis pigmentosa—the first step in this process is disrupted, and the visual system cannot transform light into images.

The Argus II Retinal Prosthesis System ("Argus II") is designed to bypass the damaged photoreceptors altogether. A miniature video camera housed in the patient’s glasses captures a scene. The video is sent to a small patient-worn computer (i.e., the video processing unit – VPU) where it is processed and transformed into instructions that are sent back to the glasses via a cable. These instructions are transmitted wirelessly to an antenna in the implant. The signals are then sent to the electrode array, which emits small pulses of electricity. These pulses are intended to bypass the damaged photoreceptors and stimulate the retina’s remaining cells, which transmit the visual information along the optic nerve to the brain. This process is intended to create the perception of patterns of light which patients can learn to interpret as visual patterns.

2) Retina Implant AG:

Retina Implant AG is another company based in Germany that is developing their own retinal implant for patients with retinal degenerations. With their chip, they envisage that it should become possible again for a patient to move freely and independently without another person’s assistance. It is also conceivable that objects and faces could become recognisable again. A component of the early research into this implant was performed by the Tyndall institute in Cork and was funded by Fighting Blindness. One of the founders of Retina Implant AG, Professor Eberhart Zrenner was the keynote speaker at the Retina 2012 conference organised by Fighting Blindness in Dublin.

They are developing microchips to be surgically implanted beneath the transparent top membrane of the retina and into the macular region. The chip senses light and transmits light signals back to the brain. The implant is controlled by a handheld, battery powered device which receives signals from a small device that is implanted under the skin behind the ear.

Dr. Stanislao RIZZO talk on Artificial Retina-Argus II

PDF Understand Retinitis Pigmentosa

PDF Retinitis Pigmentosa Research Advances 2014

 What is Age-Related Macular Degeneration (AMD)?

AMD is a common eye disease associated with aging that gradually destroys sharp, central vision; Central vision is needed for seeing objects clearly and for common daily tasks such as reading and driving. In some people AMD advances so slowly that it will have little effect on their vision as they age. But in others, the disease progresses faster and may lead to a loss of vision in one or both eyes.(www.amd.org)In Retinitis Pigmentosa & AMD patients are visually impaired due to loss of photoreceptors, the light-sensing cells of the eye. Researchers are trying to develop a silicon microchip which will replace the photoreceptor layer of the retina and act as an artificial retina. The tiny self-contained chip, slightly larger than the head of a pin, is surgically implanted on the retina at the back of the eye. The chip contains microscopic solar cells that are designed to convert light energy into thousands of electrical impulses. These signals would then stimulate the intact, functional cells of the retina in patients with photoreceptor cell damage. This stimulation induces biological visual signals in the good retinal tissue. The nerve fiber layer of the retina can then do its job of sending these electrical signals to the brain, via the optic nerve.Researchers are currently working on two models depending on the layer of the retina that this implant will be placed upon. The implant can either be placed on the surface of the retina as shown in the figure on the left or within the retinal layers as shown in the figure on the left Researchers are currently working on two models depending on the layer of the retina that this implant will be placed upon. The implant can either be placed on the surface of the retina as shown in the figure on the left or within the retinal layers as shown in the figure on the right. Researchers from all over the world are making attempts to fabricate such a device. Some groups have already tested the clip in human trials and reported improved vision.

 Stem Cell Research:

The eye's cornea is the clear tissue that allows light to enter the eye. It also refracts light rays to focus onto the retina between the cornea and the sclera, the eyeball's white outer coating, is the limbus, where some very important cells reside. Limbal stem cells are the mother cells and give rise to the corneal epithelial cells. Severe damage to limbal stem cell significantly impairs a person's vision. To treat cases of limbal stem cell deficiency, the limbal stem cells are taken from the healthy eye or donor eye and then transplanted to the affected eye. If the transplant is successful the limbal stem cells will produce a new layer of epithelial cells in the patient's eye. The success rate of growing the new cells from transplanted limbal stem cell varies. The eye's cornea is the clear tissue that allows light to enter the eye. It also refracts light rays to focus onto the retina between the cornea and the sclera, the eyeball's white outer coating, is the limbus, where some very important cells reside. Limbal stem cells are the mother cells and give rise to the corneal epithelial cells. Severe damage to limbal stem cell significantly impairs a person's vision. To treat cases of limbal stem cell deficiency, the limbal stem cells are taken from the healthy eye or donor eye and then transplanted to the affected eye. If the transplant is successful the limbal stem cells will produce a new layer of epithelial cells in the patient's eye. The success rate of growing the new cells from transplanted limbal stem cell varies.