Clinical Results of LUCENTIS for DR and DME


Understanding the steps on the DR scale

The DR scale measures whether your DR is getting better or worse.

The earlier stage of DR is non-proliferative diabetic retinopathy (NPDR)
  • Steps 2, 3, and 4 are considered very mild, mild, and moderate, respectively
  • Steps 5 and 6 are considered moderately severe or severe, respectively
The later stage of DR is proliferative diabetic retinopathy (PDR)
  • Steps 7 and 8 are considered mild or moderate proliferative retinopathy, respectively
  • Steps 9 and 10 are considered high risk or severe proliferative retinopathy, respectively

The DR Scale

There are 10 steps on the DR scale

A 2-step improvement is going from a 7 to a 5, for example. This might mean moving from mild PDR back down to moderately severe NPDR.

The DR scale

People treated with LUCENTIS showed improvements on the DR scale

Two studies showed significant regression, or improvement, of DR with LUCENTIS
Improvements of 2 or more steps were shown in 2 studies of a total of 473 people who had DR with DME after 2 years of treatment:

LUCENTIS MONTHLY


38%

88 of 234 people (37.6%) improved by 2 or more steps

NO LUCENTIS


5%

13 of 239 people (5.4%) improved by 2 or more steps

Improvements of 3 or more steps were shown in the same 2 studies of a total of 473 people who had DR with DME after 2 years of treatment:

LUCENTIS MONTHLY


13%

31 of 234 people (13.2%) improved by 3 or more steps

NO LUCENTIS


1%

3 of 239 people (1.3%) improved by 3 or more steps

In a third study, 189 affected eyes of people who had DR with and without DME were treated monthly with LUCENTIS for 3 months, followed by treatment as required for 2 years:

Improvements of 2 or more steps


58%

24 of 41 eyes (58.5%) with DME improved by 2 or more steps on the DR scale

38%

56 of 148 eyes (37.8%) without DME improved by 2 or more steps on the DR scale

Improvements of 3 or more steps


32%

13 of 41 eyes (31.7%) with DME improved by 3 or more steps on the DR scale

28%

42 of 148 eyes (28.4%) without DME improved by 3 or more steps on the DR scale


LUCENTIS can help people who have DR with DME see more letters on an eye chart

In 2 studies of a total of 507 people who had DR with DME after 2 years:
Study results from a study of 459 people with wet AMD after 1 year of treatment

LUCENTIS can also help improve* vision in people who have DR with DME

In the same 2 studies, more people who received LUCENTIS monthly were able to read an additional 15 letters on an eye chart at 2 years:

LUCENTIS MONTHLY


39%

(98 of 250 people; 39.2%)

NO LUCENTIS


15%

(39 of 257 people; 15.2%)

*Improvement is defined as reading an additional 15 or more letters on an eye chart.


Financial Assistance Options

Financial Assistance Options

There may be options to help you afford LUCENTIS, no matter what type of health insurance you have. Learn about Genentech Ophthalmology Access Solutions.

Important Safety Information & Indication

Who is LUCENTIS for? LUCENTIS® (ranibizumab injection) is a prescription medicine for the treatment of patients with diabetic retinopathy (DR) and diabetic macular edema (DME).

What important safety information should I know about LUCENTIS? You should not use LUCENTIS if you have an infection in or around the eye or are allergic to LUCENTIS or any of its ingredients. LUCENTIS is a prescription medication given by injection into the eye, and it has side effects. Some LUCENTIS patients have had detached retinas and serious eye infections. If your eye becomes red, sensitive to light, or painful, or if you have a change in vision, call or visit your eye doctor right away. 

Some LUCENTIS patients have had increases in eye pressure before and within 1 hour of an injection.

Uncommonly, LUCENTIS patients have had serious, sometimes fatal, problems related to blood clots, such as heart attacks or strokes. Fatal events were seen more often in patients with DME and DR with LUCENTIS compared with patients who did not receive LUCENTIS. Although there were only few fatal events which included causes of death typical of patients with advanced diabetic complications, these events may be caused by LUCENTIS.

Severe inflammation of vessels in the retina has happened for patients treated with LUCENTIS. Call your healthcare provider immediately if you experience a change in vision.

Some LUCENTIS patients have serious side effects related to the injection. These include serious infections inside the eye, detached retinas, and cataracts. The most common eye-related side effects are increased redness in the white of the eye, eye pain, small specks in vision, and increased eye pressure. The most common non–eye-related side effects are nose and throat infections, anemia, nausea and cough. Ask your doctor if you have questions or want more information.

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

For additional Safety Information, please talk to your doctor and see the LUCENTIS full Prescribing Information.