16 November, 2015

Injection better cure for diabetic blindness

Washington: A new study has revealed that injection, instead of laser, may be a viable treatment option for diabetic retinopathy.

Among patients with proliferative diabetic retinopathy, treatment with an injection in the eye of the drug ranibizumab resulted in visual acuity that was not worse than panretinal photocoagulation at 2 years, according to the study.

Proliferative diabetic retinopathy (PDR; a more advanced form of the disease) is a leading cause of vision loss in patients with diabetes mellitus, resulting in 12,000 to 24,000 new cases of blindness each year in the United States.

When used as treatment of DME, intravitreous (in the vitreous, the fluid behind the lens in the eye) anti-vascular endothelial growth factor (VEGF) agents reduce the risk of diabetic retinopathy worsening and increase the chance of improvement, making these agents a potentially viable PDR treatment.

"Although longer-term follow-up is needed, ranibizumab may be a reasonable treatment alternative at least through 2 years for patients with PDR," the authors write.

The study appears in JAMA.

Source: www.zeenews.india.com

16.11.2015

Govt initiates steps to promote clinical research in India

New Delhi: In a new development, the government of India has introduced a series of steps that would help promote more clinical research in the country.

In its latest circular issued this week, the Central Drug Standard Control Organization (CDSCO) said if a new drug was already approved outside India after conducting pre-clinical/toxicological studies on animals, such studies are not required to be repeated while approving their proposal for import or manufacture in India unless some specific concerns are raised.

The move comes in wake of concerns raised by stakeholders which complained of repeat tests and data submissions to authorities in meetings held in August and October with top officials from the health ministry.

In another decision, the Drug Controller General of India (DCGI) has said that Ethics Committees can also approve requests for new clinical trial sites and new investigators to be added to a clinical trial without CDSCO’s approval as long as the ethics committees conduct “due diligence.”

As per the new norms, researchers will no longer need the permission of the Drug Controller General of India (DCGI) for “academic/research purposes that are non-regulatory in nature.” However, the Ethics Committee is still required to inform the DCGI of the study and the DCGI will have 30 days to object to the decision to not seek its approval.

Source: www.zeenews.india.com

16.11.2015

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